The following data is part of a premarket notification filed by Syntex Dental Products, Inc. with the FDA for Precapsuled Dental Amalgam.
| Device ID | K822610 |
| 510k Number | K822610 |
| Device Name: | PRECAPSULED DENTAL AMALGAM |
| Classification | Capsule, Dental, Amalgam |
| Applicant | SYNTEX DENTAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZS |
| CFR Regulation Number | 872.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-30 |
| Decision Date | 1982-09-14 |