The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Etchant 40%.
| Device ID | K030743 |
| 510k Number | K030743 |
| Device Name: | ETCHANT 40% |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Contact | Stephen Rudolph |
| Correspondent | Stephen Rudolph CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020558 | K030743 | 000 |
| 00816519020541 | K030743 | 000 |
| 00816519020534 | K030743 | 000 |
| 00816519020527 | K030743 | 000 |