The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Customizable Gingiva Former.
| Device ID | K092248 |
| 510k Number | K092248 |
| Device Name: | SPI CUSTOMIZABLE GINGIVA FORMER |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, SUITE 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 | 2009-07-28 |
| Decision Date | 2009-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156473414 | K092248 | 000 |
| 07640156473407 | K092248 | 000 |
| 07640156473391 | K092248 | 000 |
| 07640156473384 | K092248 | 000 |
| 07640156473377 | K092248 | 000 |