The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Chemical Cure Composite Restorative Material.
Device ID | K994224 |
510k Number | K994224 |
Device Name: | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL |
Classification | Material, Tooth Shade, Resin |
Applicant | PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
Contact | Rolando Marasigan |
Correspondent | Rolando Marasigan PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-15 |
Decision Date | 2000-01-31 |