The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Triad Orthodontic Gel.
| Device ID | K882482 |
| 510k Number | K882482 |
| Device Name: | TRIAD ORTHODONTIC GEL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | John O Semmelman |
| Correspondent | John O Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-16 |
| Decision Date | 1988-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D82813390010 | K882482 | 000 |