K193388 is an FDA 510(k) clearance for the GlassLok Kits, GlassLok Powder, GlassLok Liquid. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on April 27, 2020, 143 days after receiving the submission on December 6, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K193388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2019 |
| Decision Date | April 27, 2020 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |