GC Ortho Connect, GC Ortho Etching Gel

FDA 510(k) K150128 · Gc Orthodontics America, Inc.

Substantially Equivalent

510(k) numberK150128

Submission

Device name
GC Ortho Connect, GC Ortho Etching Gel
Applicant
Gc Orthodontics America, Inc.
Alsip, IL, US
Received
January 20, 2015
Decision date
July 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DYH – Adhesive, Bracket And Tooth Conditioner, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3750
Specialty
Dental

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Questions and answers

When was GC Ortho Connect, GC Ortho Etching Gel cleared by the FDA?

GC Ortho Connect, GC Ortho Etching Gel (K150128) received a 510(k) decision of Substantially Equivalent on July 16, 2015, 177 days after the submission was received.

What is the product code of K150128?

The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.