FDA 510(k)

PADLOCK

K-Number: K111814 · 2011-09-14

ApplicantReliance Orthodontic Products, Inc.

Decision Date2011-09-14

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PADLOCK 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 2011-09-14 under 510(k) number K111814. 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 PADLOCK?

PADLOCK is a medical device that received FDA 510(k) clearance on 2011-09-14. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K111814.

When did PADLOCK receive FDA 510(k) clearance?

PADLOCK received FDA 510(k) clearance on 2011-09-14, under 510(k) number K111814.

Who is the listed applicant for PADLOCK?

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 PADLOCK?

The FDA product code for PADLOCK is DYH.

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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.