NobelReplace® Conical Connection TiUltra™ 300348Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ RP 5.0x10mm · Class 2 · Implant

All models of NobelReplace Conical Connection TiUltra (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This NobelReplace TiUltra dental implant is a root-form implant placed in the jawbone. Its 3,252 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting infection, abscess and pain. The reports include no deaths and 3,226 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 3,289
Deaths reported: 0
Injuries reported: 3,263
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3,289 adverse event reports that list this exact device (DI 07332747128390), received between Nov 1, 2021 and Sep 30, 2026 — classified as 3,263 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2,445 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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Osseointegrate2,445
Loss of Osseointegration445
Osseointegration Problem210
Adverse Event Without Identified Device or Use Problem52
Patient Device Interaction Problem41
Difficult to Insert22
Insufficient Device Problem Information22
Fracture20

Patient problems

Failure of Implant2,172
No Clinical Signs, Symptoms or Conditions852
Unspecified Infection334
Pain192
Abscess36
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available28
Numbness26
Inflammation24

Recent adverse event reports

The 25 most recent of 3,289 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50954531 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50954530 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954441 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954436 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953349 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953347 ↗
InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940590 ↗
InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940588 ↗
InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940570 ↗
InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940566 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829978 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829977 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829935 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829926 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810473 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810469 ↗
InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796148 ↗
InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796146 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796116 ↗
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796111 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749078 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749075 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749070 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749062 ↗
InjurySep 11, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741994 ↗

Device details

UDI-DI	`07332747128390`
Brand	NobelReplace® Conical Connection TiUltra™
Model	300348
Company	Nobel Biocare AB
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 7, 2025

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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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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