The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Dispersalloy-dispersed Phase Alloy Self-.
| Device ID | K802967 |
| 510k Number | K802967 |
| Device Name: | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- |
| Classification | Capsule, Dental, Amalgam |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | DZS |
| CFR Regulation Number | 872.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-21 |
| Decision Date | 1980-12-30 |