The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Etch-detect.
| Device ID | K991099 |
| 510k Number | K991099 |
| Device Name: | AMERICAN DENTAL PRODUCTS ETCH-DETECT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville, IL 60106 -1329 |
| Contact | George Nicolae |
| Correspondent | George Nicolae AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville, IL 60106 -1329 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-10 |
| Summary: | summary |