The following data is part of a premarket notification filed by Nanzee Dental Products with the FDA for Plastic Tooth Reinforcement Kit.
| Device ID | K895758 |
| 510k Number | K895758 |
| Device Name: | PLASTIC TOOTH REINFORCEMENT KIT |
| Classification | Pin, Retentive And Splinting, And Accessory Instruments |
| Applicant | NANZEE DENTAL PRODUCTS 950 TAXVILLE RD. York, PA 17404 |
| Contact | Albert G Munchel |
| Correspondent | Albert G Munchel NANZEE DENTAL PRODUCTS 950 TAXVILLE RD. York, PA 17404 |
| Product Code | EBL |
| CFR Regulation Number | 872.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-12-20 |