The following data is part of a premarket notification filed by Silicon-und Composite Spezialitaten Gmbh with the FDA for Multi-prime Aka/mono-prime.
| Device ID | K953476 |
| 510k Number | K953476 |
| Device Name: | MULTI-PRIME AKA/MONO-PRIME |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SILICON-UND COMPOSITE SPEZIALITATEN GMBH OFFENAUER WEG 19 Bokholt-hanredder, DE D-25335 |
| Contact | Jurgen Englebrecht |
| Correspondent | Jurgen Englebrecht SILICON-UND COMPOSITE SPEZIALITATEN GMBH OFFENAUER WEG 19 Bokholt-hanredder, 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 | 1995-07-24 |
| Decision Date | 1995-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J0229008231 | K953476 | 000 |