The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zeno Pmma Disc.
| Device ID | K080182 |
| 510k Number | K080182 |
| Device Name: | ZENO PMMA DISC |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020276 | K080182 | 000 |
| 00889024014510 | K080182 | 000 |
| 00889024015562 | K080182 | 000 |
| 00889024014800 | K080182 | 000 |
| 00889024014442 | K080182 | 000 |
| 00889024014374 | K080182 | 000 |