The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Sebond Pink Light 5g, Sebond Pink Dark 5g, Sebond Smart 5ml, Sebond Grip 3g, Models 644090, 644091, 640066, 644092.
| Device ID | K051050 |
| 510k Number | K051050 |
| Device Name: | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 |
| 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 | 2005-04-25 |
| Decision Date | 2005-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260576941527 | K051050 | 000 |