The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Infiltration Kit.
| Device ID | K100062 |
| 510k Number | K100062 |
| Device Name: | INFILTRATION KIT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-11 |
| Decision Date | 2010-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2204031 | K100062 | 000 |
| EDMG2204021 | K100062 | 000 |
| EDMG2204011 | K100062 | 000 |
| EDMG2204000 | K100062 | 000 |
| EDMG2203850 | K100062 | 000 |