SuperLine IIRecalls & reported problems across all models

Dentium USA · 23 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 424
Deaths reported: 0
Injuries reported: 424
Recalls: 0

We found 23 models of SuperLine II by Dentium USA in the FDA's device registry (GUDID). Together they are named in 424 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2021 and Jul 14, 2026 — classified as 424 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (379 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Most reported SuperLine II problems

Device problems

Failure to Osseointegrate379
Loss of Osseointegration39
Osseointegration Problem5
Fracture1

Patient problems

Inadequate Osseointegration424
Failure of Implant409
Unspecified Infection125
Pain58
Discomfort1
Patient Problem/Medical Problem1

SuperLine II models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

SuperLine II FXS4010C
IMPLANT, ENDOSSEOUS, ROOT-FORM
63 reports
SuperLine II FXS3610C
IMPLANT, ENDOSSEOUS, ROOT-FORM
55 reports
SuperLine II FXS4510C
IMPLANT, ENDOSSEOUS, ROOT-FORM
52 reports
SuperLine II FXS5010C
IMPLANT, ENDOSSEOUS, ROOT-FORM
41 reports
SuperLine II FXS4508C
IMPLANT, ENDOSSEOUS, ROOT-FORM
37 reports
SuperLine II FXS3612C
IMPLANT, ENDOSSEOUS, ROOT-FORM
29 reports
SuperLine II FXS4008C
IMPLANT, ENDOSSEOUS, ROOT-FORM
25 reports
SuperLine II FXS4012C
IMPLANT, ENDOSSEOUS, ROOT-FORM
23 reports
SuperLine II FXS5008C
IMPLANT, ENDOSSEOUS, ROOT-FORM
23 reports
SuperLine II FXS4512C
IMPLANT, ENDOSSEOUS, ROOT-FORM
21 reports
SuperLine II FXS3608C
IMPLANT, ENDOSSEOUS, ROOT-FORM
11 reports
SuperLine II FXS4507BC
Implant, Endosseous, Root-Form
11 reports
SuperLine II FXS4007BC
Implant, Endosseous, Root-Form
6 reports
SuperLine II FXS5012C
IMPLANT, ENDOSSEOUS, ROOT-FORM
6 reports
SuperLine II FXS4014C
IMPLANT, ENDOSSEOUS, ROOT-FORM
4 reports
SuperLine II FXS4514C
IMPLANT, ENDOSSEOUS, ROOT-FORM
4 reports
SuperLine II FXS6010C
IMPLANT, ENDOSSEOUS, ROOT-FORM
4 reports
SuperLine II FXS3614C
IMPLANT, ENDOSSEOUS, ROOT-FORM
2 reports
SuperLine II FXS4507C
Implant, Endosseous, Root-Form
2 reports
SuperLine II FXS6008C
IMPLANT, ENDOSSEOUS, ROOT-FORM
2 reports
SuperLine II FXS3607BC
Implant, Endosseous, Root-Form
1 report
SuperLine II FXS5007BC
Implant, Endosseous, Root-Form
1 report
SuperLine II FXS6007C
Implant, Endosseous, Root-Form
1 report

Recent SuperLine II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

InjuryJul 14, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 1 MONTH AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. NO SIGNIFICANT FINDINGS WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25820747 ↗
InjuryJul 6, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY , APPROXIMATELY 1 MONTH AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE.LOCAL INFECTION WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 25724422 ↗
InjuryJun 16, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 3 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE I. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. LOCAL INFECTION AND PERI-IMPLANTITIS WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 25527217 ↗
InjuryJun 11, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25480310 ↗
InjuryJun 11, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 14 DAYS AFTER IMPLANT PLACEMENT. PATIENT'S X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS NOT REPORTED. LOCAL INFECTION AND PAIN WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 25480284 ↗
InjuryJun 11, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 3 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25480281 ↗
InjuryJun 11, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 17 DAYS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PAIN WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 25480280 ↗
InjuryJun 11, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 8 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25480279 ↗
InjuryJun 2, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS NOT PROVIDED. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERIODONTAL DISEASE AND BONE RESORPTION WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25368317 ↗
InjuryJun 2, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS NOT PROVIDED. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERIODONTAL DISEASE AND BONE RESORPTION WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25368316 ↗
InjuryJun 2, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 2 MONTHS AFTER IMPLANT PLACEMENT. PATIENT'S X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS NOT PROVIDED. BONE RESORPTION WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25368315 ↗
InjuryJun 2, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERI-IMPLANTITIS, LOCAL INFECTION, AND PAIN WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 25368314 ↗
InjuryJun 2, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS NOT PROVIDED. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERIODONTAL DISEASE AND BONE RESORPTION WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25368311 ↗
InjuryMay 13, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 13 DAYS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE I. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25166437 ↗
InjuryMay 13, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 2 MONTHS AFTER IMPLANT PLACEMENT. THE PATIENT'S X-RAY WAS PROVIDED. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. MOBILITY WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 25166350 ↗

Other Dentium USA products

All Dentium USA devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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