PEEK Biosolution
Material, Tooth Shade, Resin
Merz Dental GmbH
The following data is part of a premarket notification filed by Merz Dental Gmbh with the FDA for Peek Biosolution.
Pre-market Notification Details
| Device ID | K173124 |
| 510k Number | K173124 |
| Device Name: | PEEK Biosolution |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Merz Dental GmbH Eetzweg 20 Lutjenburg, DE D-24321 |
| Contact | Claudia Bobrowski |
| Correspondent | Richard G. Hunter Washington Regulatory Consultants, LLC 5616 Mariola PI Ne Albuquerque, MN 87111 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-18 |
| Summary: | summary |
Trademark Results [PEEK Biosolution]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEEK BIOSOLUTION 86255226 4750674 Live/Registered |
MERZ DENTAL GMBH 2014-04-17 |
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