Panavia™ V5 #3601-Ka
by Kuraray Noritake Dental Inc.
Panavia™ V5 #3601-Ka is a Class II device made by Kuraray Noritake Dental Inc., cleared under FDA 510(k) K150704 on 21 Aug 2015 and listed in FDA GUDID since 17 Feb 2017 (UDI-DI EKUR003601KA1), active as of 22 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 | NumberEKUR003601KA1 | Date17 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150704 | Date21 Aug 2015 | StatusActive |
Official records
- FDA 510(k) database K150704
Across registries
- FDA 510(k) K150704 decided 21 Aug 2015 Active
- FDA GUDID UDI-DI EKUR003601KA1 listed 17 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K150704
- Listed FDA GUDID EKUR003601KA1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Panavia™ V5
- Generic name
- Dental composite resin kit
- Model / reference
- #3601-KA
- Description
- Standard Kit (Universal (A2))
- Primary DI / UDI-DI
- EKUR003601KA1
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Dental composite resin kit
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code EMA (Cement, Dental).
- HYCEM APLICAP by Espe GmbH & Co. Kg.
- CLEARFIL DC CEMENT by Kuraray Medical, Inc.
- IonoStar Plus 2543 by VOCO GmbH
- DuoCem by Coltène/Whaledent AG
- CHELON-FIL by Espe GmbH (Us)
- POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT by Healex Products, Inc.
- POLYCARBONATE TEMPORARY CEMENT by Buffalo Dental Mfg Co Inc
- CARBOXYLATE CEM, PHOSPHATE CEM by S & C Polymer GmbH
- DuoTEMP 7090 by Coltène/Whaledent AG
- DEOX, OXYGEN BARRIER VISCOUS SOLUTION by ULTRADENT PRODUCTS, INC.