The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Giroc.
| Device ID | K951235 |
| 510k Number | K951235 |
| Device Name: | GIROC |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164 |
| Contact | Al Bevilacqua |
| Correspondent | Al Bevilacqua HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1995-04-20 |