Sulzer Dental, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sulzer Dental, Inc.” (first 2001, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 | 8 | 8 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (9)
Most recent Sulzer Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014050 | HEX-LOCK TEMPORARY ABUTMENT | DZE | 2002-11-13 | 338 |
| K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | NHA | 2002-03-20 | 90 |
| K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | DZE | 2002-03-19 | 88 |
| K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | DZE | 2002-01-18 | 88 |
| K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | DZE | 2001-11-19 | 53 |
| K012055 | 3.25MM SPLINE TWIST IMPLANT | DZE | 2001-09-06 | 66 |
| K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | DZE | 2001-06-25 | 63 |
| K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | DZE | 2001-05-21 | 46 |
| K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | DZE | 2001-05-15 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Sulzer Dental, 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.
- Sulzer Orthopedics, Inc. (45 510(k)s)
- Sulzer Calcitek, Inc. (9 510(k)s)
- Sulzer Carbomedics, Inc. (8 510(k)s)
- Sulzer Intratherapeutics, Inc. (8 510(k)s)
- Sulzer Spine-Tech (7 510(k)s)
- Sulzer Oscor, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sulzer Dental, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Sulzer Dental, Inc.” (first 2001, latest 2002), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sulzer Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sulzer Dental, Inc. is 66 days.
Which FDA product codes appear under Sulzer Dental, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 8); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 9 Sulzer Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Sulzer Dental, 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.