The following data is part of a premarket notification filed by Reliance Orthodontic Products Inc. with the FDA for Glasslok Kits, Glasslok Powder, Glasslok Liquid.
| Device ID | K193388 |
| 510k Number | K193388 |
| Device Name: | GlassLok Kits, GlassLok Powder, GlassLok Liquid |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 |
| Contact | Paula Wendland |
| Correspondent | Paula Wendland Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. 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 | 2019-12-06 |
| Decision Date | 2020-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798GLSB0 | K193388 | 000 |
| D798GLEB0 | K193388 | 000 |
| D798GLL150 | K193388 | 000 |
| D798GLL15B0 | K193388 | 000 |
| D798GLL250 | K193388 | 000 |
| D798GLL25B0 | K193388 | 000 |
| D798GLP1000 | K193388 | 000 |
| D798GLP150 | K193388 | 000 |
| D798GLS0 | K193388 | 000 |
| D798GLE0 | K193388 | 000 |