The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Visible Light Cure Composite Restorative Material.
| Device ID | K001108 |
| 510k Number | K001108 |
| Device Name: | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
| Contact | Rolanddo Marasigan |
| Correspondent | Rolanddo 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 | 2000-04-05 |
| Decision Date | 2000-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817441023136 | K001108 | 000 |
| 00817441022658 | K001108 | 000 |