The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Protemp(r) Garant.
| Device ID | K950203 |
| 510k Number | K950203 |
| Device Name: | PROTEMP(R) GARANT |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Contact | Antje Brechenmacher |
| Correspondent | Antje Brechenmacher ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-02-02 |