NobelParallel™ Conical Connection TiUltra™ 300296Recalls & reported problems

Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ NP 3.75x8.5mm · Class 2 · Implant

All models of NobelParallel Conical Connection TiUltra (27)

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

Quick summary

This NobelParallel TiUltra dental implant is a root-form implant placed in the jawbone. Its 3,133 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting infection, abscess and numbness. The reports include no deaths and 3,093 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: 3,159
Deaths reported: 0
Injuries reported: 3,119
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3,159 adverse event reports that list this exact device (DI 07332747127874), received between Oct 29, 2021 and Sep 30, 2026 — classified as 3,119 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2,191 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 Osseointegrate2,191
Loss of Osseointegration541
Osseointegration Problem209
Adverse Event Without Identified Device or Use Problem70
Fracture56
Patient Device Interaction Problem22
Migration20
Activation, Positioning or Separation Problem8

Patient problems

Failure of Implant2,096
No Clinical Signs, Symptoms or Conditions749
Pain248
Unspecified Infection212
Numbness71
Abscess57
Inflammation42
Implant Pain40

Recent adverse event reports

The 25 most recent of 3,159 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953701 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953698 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811438 ↗
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811434 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50781412 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50781410 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780501 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780499 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743515 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743513 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743429 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743428 ↗
InjurySep 10, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723697 ↗
InjurySep 10, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723695 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700909 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700907 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700870 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700869 ↗
InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679075 ↗
InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679071 ↗
InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678767 ↗
InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678766 ↗
InjurySep 7, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657508 ↗
InjurySep 7, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657507 ↗
InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657484 ↗

Device details

UDI-DI	`07332747127874`
Brand	NobelParallel™ Conical Connection TiUltra™
Model	300296
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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