The following data is part of a premarket notification filed by Paxmed International with the FDA for Spi Onetime Dental Implant.
| Device ID | K022038 |
| 510k Number | K022038 |
| Device Name: | SPI ONETIME DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PAXMED INTERNATIONAL 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson PAXMED INTERNATIONAL 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-07-15 |
| Summary: | summary |