The following data is part of a premarket notification filed by E&d Dental Products, Inc. with the FDA for Polyester Resin Hand Molded Tray.
| Device ID | K912820 |
| 510k Number | K912820 |
| Device Name: | POLYESTER RESIN HAND MOLDED TRAY |
| Classification | Material, Impression Tray, Resin |
| Applicant | E&D DENTAL PRODUCTS, INC. 560 SPRINGFIELD AVE. SUITE 1B Westfield, NJ 07090 |
| Contact | Edward Spehar |
| Correspondent | Edward Spehar E&D DENTAL PRODUCTS, INC. 560 SPRINGFIELD AVE. SUITE 1B Westfield, NJ 07090 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-08-21 |