The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Overdenture - Stud Attachment.
| Device ID | K890713 |
| 510k Number | K890713 |
| Device Name: | OVERDENTURE - STUD ATTACHMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-07-14 |