The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Permite Dental Amalgam Alloy.
| Device ID | K801639 |
| 510k Number | K801639 |
| Device Name: | PERMITE DENTAL AMALGAM ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-17 |
| Decision Date | 1980-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3640233032 | K801639 | 000 |
| DO3640034642 | K801639 | 000 |
| DO3640034042 | K801639 | 000 |
| DO3640033032 | K801639 | 000 |
| DO3640032022 | K801639 | 000 |
| DO3640031012 | K801639 | 000 |
| DO3640024642 | K801639 | 000 |
| DO3640024042 | K801639 | 000 |
| DO3640023032 | K801639 | 000 |
| DO3640022022 | K801639 | 000 |
| DO3640021012 | K801639 | 000 |
| DO3640050002 | K801639 | 000 |
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| DO3640232022 | K801639 | 000 |
| DO3640231012 | K801639 | 000 |
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| DO3640223032 | K801639 | 000 |
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| DO3640234042 | K801639 | 000 |