The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Provisional Inlay/onlay Kit.
Device ID | K052800 |
510k Number | K052800 |
Device Name: | PROVISIONAL INLAY/ONLAY KIT |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
Contact | Pamela Papineau |
Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2005-10-03 |
Decision Date | 2006-03-07 |
Summary: | summary |