SuperLine II FXS6010CRecalls & reported problems

Dentium USA · Endosseous dental implant · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D755FXS6010C0), received between Sep 17, 2021 and Mar 11, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Osseointegrate2
Loss of Osseointegration1
Osseointegration Problem1

Patient problems

Failure of Implant4
Inadequate Osseointegration4
Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryMar 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 3 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING 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 21579687 ↗
InjuryAug 6, 2024Osseointegration Problem; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY, 39 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDING 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 19921403 ↗
InjuryJan 5, 2022Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR 2 WEEKS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL REQUIRE ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 13162480 ↗
InjurySep 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOCAL INFECTION, HOWEVER, IT WAS ALSO ASSESSED IN THE ASPECT OF OSSEOINTEGRATION FAILURE AS THE IMPLANT WAS EXPLANTED APPROXIMATELY 1 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 12492907 ↗

Device details

UDI-DI	`D755FXS6010C0`
Brand	SuperLine II
Model	FXS6010C
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.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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