The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Periodontal Instrument #21 Goldman-fox.
| Device ID | K781035 |
| 510k Number | K781035 |
| Device Name: | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX |
| Classification | Scaler, Periodontic |
| Applicant | PREMIER DENTAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-19 |
| Decision Date | 1978-06-30 |