The following data is part of a premarket notification filed by Vita Zahnfabrik Gmbh H Rauter & Co with the FDA for Vita Akzent Lc.
| Device ID | K211854 |
| 510k Number | K211854 |
| Device Name: | VITA Akzent LC |
| Classification | Coating, Filling Material, Resin |
| Applicant | VITA Zahnfabrik GmbH H Rauter & Co Spitelgasse 3 Bad Sackingen, DE D-79713 |
| Contact | Bernd Walker |
| Correspondent | Lindsay Tilton VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, CA 92887 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2021-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J017CALCSKIT0 | K211854 | 000 |
| J017B51554250 | K211854 | 000 |
| J017B51553250 | K211854 | 000 |
| J017B51552250 | K211854 | 000 |
| J017B51551250 | K211854 | 000 |
| J017B5150R250 | K211854 | 000 |
| J017B5150M3250 | K211854 | 000 |
| J017B5150M2250 | K211854 | 000 |
| J017B5150L250 | K211854 | 000 |
| J017B5150D250 | K211854 | 000 |
| J017B5150C250 | K211854 | 000 |
| J017B5150B250 | K211854 | 000 |
| J017B51555250 | K211854 | 000 |
| J017B51556250 | K211854 | 000 |
| J017CALCEKITC0 | K211854 | 000 |
| J017CALCEKIT3D0 | K211854 | 000 |
| J017B5159050 | K211854 | 000 |
| J017B51564250 | K211854 | 000 |
| J017B51563250 | K211854 | 000 |
| J017B51562250 | K211854 | 000 |
| J017B51561250 | K211854 | 000 |
| J017B51560250 | K211854 | 000 |
| J017B51559250 | K211854 | 000 |
| J017B51558250 | K211854 | 000 |
| J017B51557250 | K211854 | 000 |
| J017B5150A250 | K211854 | 000 |