The following data is part of a premarket notification filed by Universal Implant Systems, Inc. with the FDA for Uniplant Dental Implant System.
Device ID | K011574 |
510k Number | K011574 |
Device Name: | UNIPLANT DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | UNIVERSAL IMPLANT SYSTEMS, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
Contact | Floyd G Larson |
Correspondent | Floyd G Larson UNIVERSAL IMPLANT SYSTEMS, INC. 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 | 2001-05-22 |
Decision Date | 2001-09-28 |
Summary: | summary |