A-Dec, Inc.: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “A-Dec, Inc.” (first 1989, latest 2022), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 137 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 | 1 | 167 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 76 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name A-Dec, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIA | Unit, Operative Dental | 25 | 25 |
| EFB | Handpiece, Air-Powered, Dental | 19 | 19 |
| KLC | Chair, Dental, With Operative Unit | 18 | 18 |
| EBW | Controller, Foot, Handpiece And Cord | 2 | 2 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| EBR | Unit, Suction Operatory | 1 | 1 |
| ECB | Unit, Syringe, Air And/Or Water | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| FLE | Sterilizer, Steam | 1 | 1 |
Review panels
- Dental (68)
- General Hospital (1)
Most recent A-Dec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213932 | A-dec 300, A-dec 500 | EIA | 2022-03-02 | 76 |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | EBW | 2014-05-28 | 167 |
| K102234 | A-DEC 200 DENTAL SYSTEM | EIA | 2010-11-24 | 107 |
| K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | ELC | 2010-07-09 | 123 |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | EFB | 2009-01-15 | 120 |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | EFB | 2009-01-07 | 104 |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | EIA | 2008-12-17 | 71 |
| K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | EFB | 2007-07-05 | 118 |
| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | EIA | 2005-08-30 | 70 |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | EIA | 2003-12-10 | 96 |
59 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-04-01.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under A-Dec, Inc.?
FDA lists 69 510(k) clearances under the applicant name “A-Dec, Inc.” (first 1989, latest 2022), across 9 product codes in 2 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 A-Dec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A-Dec, Inc. is 137 days.
Which FDA product codes appear under A-Dec, Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 25); EFB (Handpiece, Air-Powered, Dental, 19); KLC (Chair, Dental, With Operative Unit, 18).
Next steps
- See all 69 A-Dec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, A-Dec, 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.