NobelParallel™ Conical Connection TiUltra™ 300303Recalls & reported problems

Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ RP 4.3x8.5mm · 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 Nobel Biocare NobelParallel dental implant is placed into the jawbone. Reports most often describe the implant failing to fuse with the bone, and some mention pain, infection and inflammation. The device appears in 5,274 reports, with 5,221 injuries and no deaths. 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: 5,312
Deaths reported: 0
Injuries reported: 5,259
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5,312 adverse event reports that list this exact device (DI 07332747127959), received between Oct 29, 2021 and Sep 30, 2026 — classified as 5,259 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3,843 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 Osseointegrate3,843
Loss of Osseointegration864
Osseointegration Problem291
Adverse Event Without Identified Device or Use Problem112
Patient Device Interaction Problem60
Fracture32
Migration26
Device Markings/Labelling Problem20

Patient problems

Failure of Implant3,579
No Clinical Signs, Symptoms or Conditions1,195
Pain483
Unspecified Infection462
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available104
Inflammation103
Abscess88
Numbness80

Recent adverse event reports

The 25 most recent of 5,312 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 50954136 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954134 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953905 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953902 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953781 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953780 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953754 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953753 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50781201 ↗
InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50781199 ↗
InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780791 ↗
InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780790 ↗
InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764442 ↗
InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764441 ↗
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748694 ↗
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748690 ↗
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748497 ↗
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748495 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743329 ↗
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743318 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: Implant Pain
MAUDE report 50742883 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: Implant Pain
MAUDE report 50742882 ↗
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50723934 ↗
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50723923 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699857 ↗

Device details

UDI-DI	`07332747127959`
Brand	NobelParallel™ Conical Connection TiUltra™
Model	300303
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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