The following data is part of a premarket notification filed by Gresco Products, Inc. with the FDA for Ceram-etch.
| Device ID | K854494 |
| 510k Number | K854494 |
| Device Name: | CERAM-ETCH |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7796631040 | K854494 | 000 |
| D7796631020 | K854494 | 000 |
| D7796631010 | K854494 | 000 |
| D7796611010 | K854494 | 000 |