The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Light Bond Paste W/fluoride.
| Device ID | K895522 |
| 510k Number | K895522 |
| Device Name: | LIGHT BOND PASTE W/FLUORIDE |
| 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 | 1989-09-12 |
| Decision Date | 1989-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798LBOPS0 | K895522 | 000 |
| D798LBEBTF0 | K895522 | 000 |
| D798LBEMPF0 | K895522 | 000 |
| D798LBEPF0 | K895522 | 000 |
| D798LBESF0 | K895522 | 000 |
| D798LBETFLN0 | K895522 | 000 |
| D798LBETPF0 | K895522 | 000 |
| D798LBETTF0 | K895522 | 000 |
| D798LBFS7F0 | K895522 | 000 |
| D798LBEBPF0 | K895522 | 000 |
| D798LBBPTF1 | K895522 | 000 |
| D798LBEMP0 | K895522 | 000 |
| D867CLABC0 | K895522 | 000 |
| D798APP0 | K895522 | 000 |
| D798BILBP0 | K895522 | 000 |
| D798BILBPF0 | K895522 | 000 |
| D798LBBPP0 | K895522 | 000 |
| D798LBBPPF0 | K895522 | 000 |
| D798LBBPT1 | K895522 | 000 |
| D798LBFSF0 | K895522 | 000 |
| D798LBMP0 | K895522 | 000 |
| D798LBS7F0 | K895522 | 000 |
| D798LBTPP0 | K895522 | 000 |
| D798LBTPPF0 | K895522 | 000 |
| D798LBTPT1 | K895522 | 000 |
| D798LBTPTF1 | K895522 | 000 |
| D798LBEMTF0 | K895522 | 000 |
| D798LBET0 | K895522 | 000 |
| D798LBETF0 | K895522 | 000 |
| D798LBS3F0 | K895522 | 000 |
| D798LBPTLN1 | K895522 | 000 |
| D798LBMPPF0 | K895522 | 000 |
| D798LBMPT1 | K895522 | 000 |
| D798LBMPTF1 | K895522 | 000 |
| D798LBPPF0 | K895522 | 000 |
| D798LBPSF0 | K895522 | 000 |
| D798LBPT1 | K895522 | 000 |
| D798LBPTF1 | K895522 | 000 |
| D798LBPTFLN1 | K895522 | 000 |
| 00817645020184 | K895522 | 000 |