The following data is part of a premarket notification filed by Collagen Corp. with the FDA for Osseodent Dental Attachments.
Device ID | K895462 |
510k Number | K895462 |
Device Name: | OSSEODENT DENTAL ATTACHMENTS |
Classification | Implant, Endosseous, Root-form |
Applicant | COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
Contact | Cindy Domecus |
Correspondent | Cindy Domecus COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-06 |
Decision Date | 1990-04-04 |