The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Porcelain Primer.
Device ID | K880790 |
510k Number | K880790 |
Device Name: | PORCELAIN PRIMER |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143 |
Contact | Paul A Gange |
Correspondent | Paul A Gange RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-04-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D82813309010 | K880790 | 000 |
D798PO0 | K880790 | 000 |
00817645020191 | K880790 | 000 |