The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Composite Restorative, Paste/paste Type.
Device ID | K790789 |
510k Number | K790789 |
Device Name: | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE |
Classification | Material, Tooth Shade, Resin |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-24 |
Decision Date | 1979-07-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D801SP56161 | K790789 | 000 |
D801SP540411 | K790789 | 000 |
D801SP540421 | K790789 | 000 |
D801SP5404S1 | K790789 | 000 |
D801SP54051 | K790789 | 000 |
D801SP5405S1 | K790789 | 000 |
D801SP55041 | K790789 | 000 |
D801SP550411 | K790789 | 000 |
D801SP550421 | K790789 | 000 |
D801SP5504S1 | K790789 | 000 |
D801SP56151 | K790789 | 000 |
D801SP54041 | K790789 | 000 |