The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Alloy For Dental Amalgam Luxalloy Non Gamma 2.
| Device ID | K870230 |
| 510k Number | K870230 |
| Device Name: | ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 |
| Classification | Alloy, Amalgam |
| Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
| Contact | Dr. J Rothaut |
| Correspondent | Dr. J Rothaut DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-05-20 |