The following data is part of a premarket notification filed by Paxmed International with the FDA for Quantum Versatility (qvs) Dental Implant System.
Device ID | K011223 |
510k Number | K011223 |
Device Name: | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-20 |
Decision Date | 2001-09-20 |