The following data is part of a premarket notification filed by Mycone Dental Supply Co., Inc. with the FDA for Seity 37% Phosphoric Acid Etchant Gel.
| Device ID | K112597 |
| 510k Number | K112597 |
| Device Name: | SEITY 37% PHOSPHORIC ACID ETCHANT GEL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Contact | William Evans |
| Correspondent | William Evans MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D820DETCH30 | K112597 | 000 |
| D820DETCH120 | K112597 | 000 |