KV-Adaptor
KV-Adaptor is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K163483 on 15 Aug 2017 (1 earlier submission) and listed in FDA GUDID since 1 Jul 2020 (UDI-DI 04560264573376), active as of 20 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 | Number04560264573376 | Date1 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163483 | Date15 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 04560264573376
- FDA 510(k) database K163483
- FDA 510(k) database K081811
Across registries
- FDA 510(k) K163483 decided 15 Aug 2017 Active
- FDA GUDID UDI-DI 04560264573376 listed 1 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K081811
- Cleared FDA 510(k) K163483
- Listed FDA GUDID 04560264573376
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental handpiece maintenance unit
- Model / reference
- KV-Adaptor
- Primary DI / UDI-DI
- 04560264573376
- FDA product code
- EFB
- GMDN term
- Dental handpiece maintenance unit
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code EFB (Handpiece, air-powered, dental).
- PANA SPRAY PLUS by Nsk America Corp.
- AIR-FLOW handy 3.0 PLUS by E.M.S. Electro Medical Systems S.A.
- CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO by Castellini S.P.A.
- SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT by Handpiece Headquarters
- T1 LINE 3328437 by SIRONA Dental Systems GmbH
- PERIO-FLOW nozzle by E.M.S. Electro Medical Systems S.A.
- High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) by Foshan SOCO Precision Instrument Co., Ltd.
- A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT by A-Dec, Inc.
- COXO CX207-A by Foshan COXO Medical Instrument Co., Ltd.
- FIBER OPTIC HANDPIECE by Syntex Corp.