The following data is part of a premarket notification filed by Gc Orthodontics America Inc. with the FDA for Gc Ortho Connect, Gc Ortho Etching Gel.
| Device ID | K150128 |
| 510k Number | K150128 |
| Device Name: | GC Ortho Connect, GC Ortho Etching Gel |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | GC Orthodontics America Inc. 11535 S.Central Avenue Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC Orthodontics America Inc. 11535 S.Central Avenue Alsip, IL 60803 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E53590140000001 | K150128 | 000 |
| E53590110000001 | K150128 | 000 |
| E53590410000001 | K150128 | 000 |
| E53590310000001 | K150128 | 000 |