The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Adhesive, Bracket And Tooth Conditioner Resin.
| Device ID | K921283 |
| 510k Number | K921283 |
| Device Name: | ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Arun Prasad |
| Correspondent | Arun Prasad JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-12-23 |