The following data is part of a premarket notification filed by Golden Dental Products, Inc. with the FDA for Py-rite.
| Device ID | K853758 |
| 510k Number | K853758 |
| Device Name: | PY-RITE |
| Classification | Lens, Spectacle (prescription), For Reading Discomfort |
| Applicant | GOLDEN DENTAL PRODUCTS, INC. 16000 W. 76TH. AVE. Golden, CO 80403 |
| Contact | Don White |
| Correspondent | Don White GOLDEN DENTAL PRODUCTS, INC. 16000 W. 76TH. AVE. Golden, CO 80403 |
| Product Code | NJH |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-12-03 |