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 |
|---|---|---|
| D6620709002250 | K801639 | 000 |
| DO3640221012 | K801639 | 000 |
| DO3640222022 | K801639 | 000 |
| DO3640223032 | K801639 | 000 |
| DO3640224042 | K801639 | 000 |
| DO3640224642 | K801639 | 000 |
| DO3640231012 | K801639 | 000 |
| DO3640232022 | K801639 | 000 |
| DO3640233032 | K801639 | 000 |
| DO3640234042 | K801639 | 000 |
| DO3640250002 | K801639 | 000 |
| DO3640502022 | K801639 | 000 |
| DO3640503032 | K801639 | 000 |
| DO3640602022 | K801639 | 000 |
| DO3640603032 | K801639 | 000 |
| DO3642012022 | K801639 | 000 |
| DO3642013032 | K801639 | 000 |
| DO3642014042 | K801639 | 000 |
| DO3640214042 | K801639 | 000 |
| DO3640213032 | K801639 | 000 |
| DO3640011012 | K801639 | 000 |
| DO3640012022 | K801639 | 000 |
| DO3640013032 | K801639 | 000 |
| DO3640014042 | K801639 | 000 |
| DO3640021012 | K801639 | 000 |
| DO3640022022 | K801639 | 000 |
| DO3640023032 | K801639 | 000 |
| DO3640024042 | K801639 | 000 |
| DO3640024642 | K801639 | 000 |
| DO3640031012 | K801639 | 000 |
| DO3640032022 | K801639 | 000 |
| DO3640033032 | K801639 | 000 |
| DO3640034042 | K801639 | 000 |
| DO3640034642 | K801639 | 000 |
| DO3640050002 | K801639 | 000 |
| DO3640211012 | K801639 | 000 |
| DO3640212022 | K801639 | 000 |
| DO3642022022 | K801639 | 000 |
| DO3642023032 | K801639 | 000 |
| DO3644023032 | K801639 | 000 |
| DO3644024042 | K801639 | 000 |
| DO3644032022 | K801639 | 000 |
| DO3644033032 | K801639 | 000 |
| DO3644034042 | K801639 | 000 |
| DO3644050002 | K801639 | 000 |
| DO3644212022 | K801639 | 000 |
| DO3644213032 | K801639 | 000 |
| DO3644214042 | K801639 | 000 |
| DO3644222022 | K801639 | 000 |
| DO3644223032 | K801639 | 000 |
| DO3644224042 | K801639 | 000 |
| DO3644232022 | K801639 | 000 |
| DO3644233032 | K801639 | 000 |
| DO3644234042 | K801639 | 000 |
| DO3644250002 | K801639 | 000 |
| DO3644503032 | K801639 | 000 |
| DO3644022022 | K801639 | 000 |
| DO3644014042 | K801639 | 000 |
| DO3642024042 | K801639 | 000 |
| DO3642032022 | K801639 | 000 |
| DO3642033032 | K801639 | 000 |
| DO3642034042 | K801639 | 000 |
| DO3642050002 | K801639 | 000 |
| DO3642212022 | K801639 | 000 |
| DO3642213032 | K801639 | 000 |
| DO3642214042 | K801639 | 000 |
| DO3642222022 | K801639 | 000 |
| DO3642223032 | K801639 | 000 |
| DO3642224042 | K801639 | 000 |
| DO3642232022 | K801639 | 000 |
| DO3642233032 | K801639 | 000 |
| DO3642234042 | K801639 | 000 |
| DO3642250002 | K801639 | 000 |
| DO3644012022 | K801639 | 000 |
| DO3644013032 | K801639 | 000 |
| DO3644603032 | K801639 | 000 |