The following data is part of a premarket notification filed by Solar Dental Co., Inc. with the FDA for Solarcry/temporary Crown & Bridge Mat.
Device ID | K831294 |
510k Number | K831294 |
Device Name: | SOLARCRY/TEMPORARY CROWN & BRIDGE MAT |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | SOLAR DENTAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-20 |
Decision Date | 1983-08-31 |