A-dec 11.0232.80
by A-Dec, Inc.
A-dec 11.0232.80 is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K000968 on 3 May 2000 and listed in FDA GUDID since 18 May 2022 (UDI-DI 10194665002961), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10194665002961 | Date18 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000968 | Date3 May 2000 | StatusActive |
Official records
- AccessGUDID record 10194665002961
- FDA 510(k) database K000968
Across registries
- FDA 510(k) K000968 decided 3 May 2000 Active
- FDA GUDID UDI-DI 10194665002961 listed 18 May 2022 Listed
Timeline
- Cleared FDA 510(k) K000968
- Listed FDA GUDID 10194665002961
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- A-dec
- Generic name
- Tooth dryer
- Model / reference
- 11.0232.80
- Primary DI / UDI-DI
- 10194665002961
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Tooth dryer
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code EIA (Unit, Operative Dental).
- STERILE WATER PUMP by Micro Motors, Inc.
- OPTIMA MX by Bien-Air SA Switzerland
- JACOBYSCOPE by PERIOVIEW, LLC
- EVACUATOR, ORAL CAVITY by Den-Tal-Ez Mfg Co., Inc.
- MICRODONTIC LENS by New Image Industries, Inc.
- PORT OPII, PORT OPIII by Mobile Dental Equipment Corp.
- SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES by SIRONA Dental Systems GmbH
- ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 by Dentsply Intl.
- PORT-OP by Portec, Inc.
- SPIRIT II AND SPIRIT TREATMENT CENTER by Pelton & Crane Co.