The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Easy Dental Implant Protective Cap.
| Device ID | K033346 |
| 510k Number | K033346 |
| Device Name: | SPI EASY DENTAL IMPLANT PROTECTIVE CAP |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2003-11-03 |
| Summary: | summary |