The following data is part of a premarket notification filed by Micro Dental Laboratories with the FDA for Progold Electrocoping System.
| Device ID | K980613 |
| 510k Number | K980613 |
| Device Name: | PROGOLD ELECTROCOPING SYSTEM |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 |
| Contact | Nicolas E Azar |
| Correspondent | Nicolas E Azar MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-03-09 |