The following data is part of a premarket notification filed by E&d Dental Manufacturing Co. with the FDA for Acrylic Impression Tray Materials.
| Device ID | K873739 |
| 510k Number | K873739 |
| Device Name: | ACRYLIC IMPRESSION TRAY MATERIALS |
| Classification | Material, Impression Tray, Resin |
| Applicant | E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE HILLSIDE, NJ 07205 |
| Contact | ARTHUR SCHWARTZ |
| Correspondent | ARTHUR SCHWARTZ E&D DENTAL MANUFACTURING CO. 6 HOFFMAN PLACE HILLSIDE, NJ 07205 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1988-03-07 |