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FDA 510(k)

Quantum LB

K-Number: K161684 · 2016-10-06

ApplicantReliance Orthodontic Products, Inc.
Decision Date2016-10-06
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Quantum LB is a medical device manufactured by Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2016-10-06 under approval number K161684. 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 Quantum LB?

Quantum LB is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Reliance Orthodontic Products, Inc.. The 510(k) number is K161684.

When was Quantum LB approved by the FDA?

Quantum LB received FDA 510(k) clearance on 2016-10-06, under approval number K161684.

What company makes Quantum LB?

Quantum LB is manufactured by Reliance Orthodontic Products, Inc..

What is the FDA product code for Quantum LB?

The FDA product code for Quantum LB is DYH.

Other Devices by Reliance Orthodontic Products, Inc.

K193388GlassLok Kits, GlassLok Powder, GlassLok Liquid K210349TKO Composite Bite Turbo Gel K210945Ultra SEP

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Official Source

View on FDA Database →

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

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