The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Reveneer Ceramic Repair System.
| Device ID | K052189 |
| 510k Number | K052189 |
| Device Name: | REVENEER CERAMIC REPAIR SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Contact | Michael Wierz |
| Correspondent | Michael Wierz SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB741401 | K052189 | 000 |
| EBIB740101 | K052189 | 000 |
| EBIB740201 | K052189 | 000 |
| EBIB740301 | K052189 | 000 |
| EBIB740401 | K052189 | 000 |
| EBIB740501 | K052189 | 000 |
| EBIB740801 | K052189 | 000 |
| EBIB740901 | K052189 | 000 |
| EBIB741001 | K052189 | 000 |
| EBIB741101 | K052189 | 000 |
| EBIB740001 | K052189 | 000 |