The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S&c-self Etch Pr-bond.
| Device ID | K042614 |
| 510k Number | K042614 |
| Device Name: | S&C-SELF ETCH PR-BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Christian Boettcher |
| Correspondent | Christian Boettcher S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2004-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB752651 | K042614 | 000 |
| EBIB752501 | K042614 | 000 |
| 00887919985723 | K042614 | 000 |
| 00887919985693 | K042614 | 000 |
| 00887919985662 | K042614 | 000 |