The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Dental Implant Abutments.
Device ID | K031747 |
510k Number | K031747 |
Device Name: | SPI DENTAL IMPLANT ABUTMENTS |
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 | 2003-06-05 |
Decision Date | 2003-07-02 |
Summary: | summary |