The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for Precision Dental Attachments.
Device ID | K895986 |
510k Number | K895986 |
Device Name: | PRECISION DENTAL ATTACHMENTS |
Classification | Attachment, Precision, All |
Applicant | IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
Contact | Brian R Hill |
Correspondent | Brian R Hill IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-20 |
Decision Date | 1989-10-18 |