A-dec 11.0233.00
by A-Dec, Inc.
A-dec 11.0233.00 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 24 Oct 2022 (UDI-DI 10194665005122), 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 | Number10194665005122 | Date24 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000968 | Date3 May 2000 | StatusActive |
Official records
- AccessGUDID record 10194665005122
- FDA 510(k) database K000968
Across registries
- FDA 510(k) K000968 decided 3 May 2000 Active
- FDA GUDID UDI-DI 10194665005122 listed 24 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K000968
- Listed FDA GUDID 10194665005122
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- A-dec
- Generic name
- Tooth dryer
- Model / Ref / Catalog
- 11.0233.00
- Primary DI / UDI-DI
- 10194665005122
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code EIA (Unit, Operative Dental).
- OPTI by Camsight Co., Inc.
- AIR TECHNIQUES' DENTO-VAC by Air Techniques, Inc.
- ELEC Master, ELEC Master Dual by Mgnewton, Ltd.
- PRO-SCOPE MODEL # PS-4000 by Pro-Den Systems, Inc.
- Perceptive electric dental motor and control unit by Lares Research, Inc.
- Infinity / Infinity Cross Flex Dental Systems by Olsen Indústria E Comércio S.A.
- F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT by Shanghai Fimet Medical Instrument Co., Ltd.
- AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) by Den-Tal-Ez Mfg Co., Inc.
- TPS 5100008000 5100-008-000 by Stryker Corp.
- SureSmile Aligner Software 7.6 by ORAMETRIX, INC.