Nobelpharma USA, Inc.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Nobelpharma USA, Inc.” (first 1990, latest 1999), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 158 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 51 | 51 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| EIH | Powder, Porcelain | 1 | 1 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LXB | Hearing Aid, Bone Conduction | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Nobelpharma USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | MAH | 1999-06-28 | 221 |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | DZE | 1996-09-06 | 77 |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | LXB | 1996-08-09 | 235 |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | DZE | 1996-07-22 | 49 |
| K961736 | 17 ANGULATED ABUTMENT | NHA | 1996-07-18 | 76 |
| K961737 | CERA ONE ABUTMENT SYSTEM | DZE | 1996-07-10 | 68 |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | NHA | 1996-07-10 | 68 |
| K960639 | ABUTMENT SELECTION KIT | DZE | 1996-05-14 | 90 |
| K955697 | ABUTMENT RETRIEVAL KIT | DZE | 1996-01-30 | 47 |
| K955372 | BALL ATTACHMENT SYSTEM | DZE | 1996-01-23 | 62 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nobelpharma USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nobelpharma AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nobelpharma USA, Inc.?
FDA lists 64 510(k) clearances under the applicant name “Nobelpharma USA, Inc.” (first 1990, latest 1999), across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nobelpharma USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nobelpharma USA, Inc. is 158 days.
Which FDA product codes appear under Nobelpharma USA, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 51); NHA (Abutment, Implant, Dental, Endosseous, 4); EIH (Powder, Porcelain, 1).
Next steps
- See all 64 Nobelpharma USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Nobelpharma USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.