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FDA 510(k)

GlassLok Kits, GlassLok Powder, GlassLok Liquid

K-Number: K193388 · 2020-04-27

ApplicantReliance Orthodontic Products, Inc.
Decision Date2020-04-27
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GlassLok Kits, GlassLok Powder, GlassLok Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K193388. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlassLok Kits, GlassLok Powder, GlassLok Liquid?

GlassLok Kits, GlassLok Powder, GlassLok Liquid is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K193388.

When did GlassLok Kits, GlassLok Powder, GlassLok Liquid receive FDA 510(k) clearance?

GlassLok Kits, GlassLok Powder, GlassLok Liquid received FDA 510(k) clearance on 2020-04-27, under 510(k) number K193388.

Who is the listed applicant for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

The FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid is DYH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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