Medical device manufacturer
Nobel Biocare
Nobel Biocare holds 95 FDA 510(k) clearances across 10 product codes. Median elapsed review time is 114 days. openFDA lists 2 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 95
- Product codes
- 10
- Median review
- 114 days
- Recall records
- 2
How does FDA spell Nobel Biocare?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| NOBEL BIOCARE AB | device/registrationlisting | normalised |
| Nobel Biocare | device/enforcement | normalised |
| Nobel Biocare | device/recall | normalised |
| Nobel Biocare AB | device/510k | normalised |
| Nobel Biocare AG | device/510k | normalised |
| Nobel Biocare C/O Medicim NV | device/510k | normalised |
| Nobel Biocare c/o Medicim NV | device/registrationlisting | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Nobel Biocare file in?
10 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 42 | 107 days | |
| DZE | Implant, Endosseous, Root-Form | 31 | 106 days | |
| LLZ | System, Image Processing, Radiological | 8 | 136 days | |
| ELL | Teeth, Porcelain | 5 | 120 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 156 days | |
| MYN | Analyzer, Medical Image | 2 | 138 days | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 90 days | |
| EIH | Powder, Porcelain | 1 | 179 days | |
| FZE | Prosthesis, Nose, Internal | 1 | 85 days | |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 | 225 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Nobel Biocare had a recall?
openFDA lists 2 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1101-2025Class IIOpen, ClassifiedDZE
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Z-1565-2022Class IIOpen, ClassifiedDZE
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Nobel Biocare cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252197 | Nobel Biocare S Series Implants | DZE | 219 | |
| K252086 | DTX Studio Assist | MYN | 138 | |
| K243834 | NobelZygoma TiUltra Implant system | DZE | 255 | |
| K240346 | NobelProcera Zirconia Implant Bridge | NHA | 333 | |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | NHA | 118 | |
| K231898 | DTX Studio Clinic (4.0) | LLZ | 163 | |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | NHA | 141 | |
| K221921 | DTX Studio Clinic 3.0 | MYN | 270 | |
| K213562 | DTX Studio Clinic 3.0 | LLZ | 136 | |
| K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | DZE | 79 |
Source: openFDA device/510k · retrieved
Where is Nobel Biocare registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Nobel Biocare files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.