The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Light Cure Dental Dam.
| Device ID | K021524 |
| 510k Number | K021524 |
| Device Name: | LIGHT CURE DENTAL DAM |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-19 |