SuperLine II FXS3608CRecalls & reported problems

Dentium USA · Endosseous dental implant · Class 2 · Implant

All models of SuperLine II (23)

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

Adverse event reports: 11
Deaths reported: 0
Injuries reported: 11
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI D755FXS3608C0), received between Mar 20, 2023 and Jul 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Osseointegrate9
Loss of Osseointegration1
Osseointegration Problem1

Patient problems

Failure of Implant11
Inadequate Osseointegration11
Pain1

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
InjuryJan 2, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS NOT REPORTED, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE REPORTED 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 23952411 ↗
InjuryMay 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, 16 DAYS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERI-IMPLANTITIS 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 21946645 ↗
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2023, OSSEOINTEGRATION CONFIRMED ON (B)(6) 2023, IMPLANT RESTORED (B)(6) 2024 AND REMOVED (B)(6) 2025 DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 2 YEARS AND 6 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. PERI-IMPLANTITIS AND MOBILE IMPLANT WERE OBSERVED DURING THE IMPLANT 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
MAUDE report 21770217 ↗
InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 2 YEARS AND 6 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS NOT REPORTED, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERIODONTAL DISEASE AND PAIN 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; Pain
MAUDE report 20268202 ↗
InjuryAug 6, 2024Osseointegration Problem; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY, 21 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION 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 19921360 ↗
InjuryFeb 12, 2024Failure to Osseointegrate; Failure 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 IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 18692054 ↗
InjuryJan 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 2 WEEKS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III AND IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 18546129 ↗
InjuryDec 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 18377991 ↗
InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 17195372 ↗
InjuryMar 20, 2023Failure to Osseointegrate; Failure 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 GOOD. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16579791 ↗

Device details

UDI-DI	`D755FXS3608C0`
Brand	SuperLine II
Model	FXS3608C
Company	Dentium USA
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	K160965
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Dec 30, 2024

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
43,616 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
40,404 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
27,400 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,621 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
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.

How reports and recalls are matched · Editorial policy · Report an error on this page