The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Anterior/posterior Restorative, Bond.
Device ID | K791078 |
510k Number | K791078 |
Device Name: | ANTERIOR/POSTERIOR RESTORATIVE, BOND |
Classification | Coating, Filling Material, Resin |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-12 |
Decision Date | 1979-08-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D801SP50064NN1 | K791078 | 000 |
00816526020862 | K791078 | 000 |
00816526020879 | K791078 | 000 |
00816526020886 | K791078 | 000 |
00816526020909 | K791078 | 000 |
D80150041 | K791078 | 000 |
D801SP50041 | K791078 | 000 |
D801SP500411 | K791078 | 000 |
D801SP500421 | K791078 | 000 |
D801SP500431 | K791078 | 000 |
D801SP500441 | K791078 | 000 |
D801SP5004S1 | K791078 | 000 |
00816526020855 | K791078 | 000 |