The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr.
| Device ID | K112710 |
| 510k Number | K112710 |
| Device Name: | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR |
| Classification | Powder, Porcelain |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2011-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031701497 | K112710 | 000 |
| 07630031701480 | K112710 | 000 |
| 07630031701473 | K112710 | 000 |
| 07630031701466 | K112710 | 000 |