American Dental Products, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “American Dental Products, Inc.” (first 1995, latest 2010), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 7 | 7 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 6 | 6 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| LFC | Device, Caries Detection | 1 | 1 |
Review panels
- Dental (23)
Most recent American Dental Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093014 | AMERICAN DENTAL PRODUCTS SE BONDEASY | KLE | 2010-04-16 | 199 |
| K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | LFC | 2000-03-14 | 78 |
| K991099 | AMERICAN DENTAL PRODUCTS ETCH-DETECT | EBC | 1999-06-10 | 70 |
| K973185 | AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE | KLE | 1997-11-14 | 81 |
| K964133 | AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE | KLE | 1997-01-09 | 86 |
| K954637 | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER | EBI | 1995-12-28 | 83 |
| K954876 | AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA | EMA | 1995-11-15 | 22 |
| K954701 | AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING | EBC | 1995-10-30 | 18 |
| K954408 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE | EBF | 1995-10-30 | 40 |
| K954407 | AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE | EBF | 1995-10-30 | 40 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Dental Products, 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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Dental Products, Inc.?
FDA lists 23 510(k) clearances under the applicant name “American Dental Products, Inc.” (first 1995, latest 2010), across 8 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 American Dental Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Dental Products, Inc. is 40 days.
Which FDA product codes appear under American Dental Products, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 7); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 6); KLE (Agent, Tooth Bonding, Resin, 4).
Next steps
- See all 23 American Dental Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, American Dental Products, 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.