American Dental Technologies, Inc.: FDA clearances and approvals
American Dental Technologies, Inc. has 8 FDA 510(k) clearances (first 1995, latest 2003), across 3 product codes in 2 review panels. Median 510(k) review time: 88 days.
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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
Review panels
Most recent American Dental Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023547 | DIOLASE 980 D LASER SYSTEM | GEX | 2003-04-15 | 176 |
| K012127 | PULSEMASTER ERBIUM DENTAL LASER SYSTEM | GEX | 2001-10-04 | 87 |
| K012213 | GULLIVER AND CLASSE A | EIA | 2001-08-13 | 28 |
| K984486 | PULSEMASTER DENTAL LASER SYSTEM | GEX | 1999-05-13 | 147 |
| K972325 | PULSEMASTER 1000 ST DENTAL LASER SYSTEM | GEX | 1997-09-19 | 88 |
| K961269 | PULSEMASTER | GEX | 1997-03-10 | 342 |
| K961136 | PULSEMASTER | GEX | 1996-06-03 | 74 |
| K952333 | PLASMA ARC CURING SYSTEM | EBF | 1995-08-10 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named American Dental Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does American Dental Technologies, Inc. have?
American Dental Technologies, Inc. has 8 FDA 510(k) clearances (first 1995, latest 2003), across 3 product codes in 2 review panels.
How long does FDA take to clear American Dental Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Dental Technologies, Inc.'s cleared 510(k)s is 88 days.
What devices does American Dental Technologies, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 6); EBF (Material, Tooth Shade, Resin, 1); EIA (Unit, Operative Dental, 1).
Has American Dental Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Dental Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 8 American Dental Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, American Dental Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.