The following data is part of a premarket notification filed by E&d Dental Manufacturing Co. with the FDA for Dental Handpieces And Attachment.
| Device ID | K864922 |
| 510k Number | K864922 |
| Device Name: | DENTAL HANDPIECES AND ATTACHMENT |
| Classification | File, Pulp Canal, Endodontic |
| 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 | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-16 |
| Decision Date | 1987-02-19 |