The following data is part of a premarket notification filed by Dmg America, Llc with the FDA for Etch Gel.
| Device ID | K131248 |
| 510k Number | K131248 |
| Device Name: | ETCH GEL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DMG AMERICA, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineua, Rac |
| Correspondent | Pamela Papineua, Rac DMG AMERICA, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-07-11 |
| Summary: | summary |