The following data is part of a premarket notification filed by Gresco Products, Inc. with the FDA for Enamel Etching Gel.
| Device ID | K910803 |
| 510k Number | K910803 |
| Device Name: | ENAMEL ETCHING GEL |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | GRESCO PRODUCTS, INC. 12603 EXECUTIVE DR. P.O. BOX 865 Stafford, TX 77477 |
| Contact | Clinton D Vaupel |
| Correspondent | Clinton D Vaupel GRESCO PRODUCTS, INC. 12603 EXECUTIVE DR. P.O. BOX 865 Stafford, TX 77477 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7796631030 | K910803 | 000 |