The following data is part of a premarket notification filed by E&d Dental Manufacturing Co. with the FDA for Dental Diamond Burs.
| Device ID | K871639 |
| 510k Number | K871639 |
| Device Name: | DENTAL DIAMOND BURS |
| Classification | Instrument, Diamond, Dental |
| Applicant | E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE HILLSIDE, NJ 07205 |
| Contact | ED SPEHAR |
| Correspondent | ED SPEHAR E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE HILLSIDE, NJ 07205 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-05-18 |