ENAMIC
Powder, Porcelain
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
The following data is part of a premarket notification filed by Vita Zahnfabrik H. Rauter Gmbh & Co. with the FDA for Enamic.
Pre-market Notification Details
| Device ID | K122269 |
| 510k Number | K122269 |
| Device Name: | ENAMIC |
| Classification | Powder, Porcelain |
| Applicant | VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET Brea, CA 92821 |
| Contact | Elizabeth Wolfsen |
| Correspondent | Elizabeth Wolfsen VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET Brea, CA 92821 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J017EN1EC42828850 | K122269 | 000 |
| J017EC4EM42127650 | K122269 | 000 |
| J017EN1EM42826450 | K122269 | 000 |
| J017EPMEM32827650 | K122269 | 000 |
| J017EPMEM3282765P0 | K122269 | 000 |
| J017EPMEM42827650 | K122269 | 000 |
| J017EPMEM4282765P0 | K122269 | 000 |
| J017EC4EC40628850 | K122269 | 000 |
| J017EC4EC40728850 | K122269 | 000 |
| J017EC4EC41228850 | K122269 | 000 |
| J017EC4EC42028850 | K122269 | 000 |
| J017EC4EC42828850 | K122269 | 000 |
| J017EN1EC40628850 | K122269 | 000 |
| J017EN1EC40728850 | K122269 | 000 |
| J017EN1EC41228850 | K122269 | 000 |
| J017EN1EC42028850 | K122269 | 000 |
| J017EC4EM42126450 | K122269 | 000 |
Trademark Results [ENAMIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENAMIC 86092376 4876606 Live/Registered |
Vita Zahnfabrik H. Rauter GmbH & Co. KG 2013-10-15 |
 ENAMIC 77603059 not registered Dead/Abandoned |
BIOTRONIK GmbH & Co. KG 2008-10-29 |
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