The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for Restore Self Tapping Dental Implant System.
Device ID | K924589 |
510k Number | K924589 |
Device Name: | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
Contact | Lynn Cuperus |
Correspondent | Lynn Cuperus IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-10 |
Decision Date | 1994-06-22 |