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FDA 510(k)

CLEARARCH

K-Number: K101676 · 2010-09-13

ApplicantOrmco Corp.
Decision Date2010-09-13
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARARCH is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 2010-09-13 under 510(k) number K101676. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARARCH?

CLEARARCH is a medical device that received FDA 510(k) clearance on 2010-09-13. The listed applicant is Ormco Corp.. The 510(k) number is K101676.

When did CLEARARCH receive FDA 510(k) clearance?

CLEARARCH received FDA 510(k) clearance on 2010-09-13, under 510(k) number K101676.

Who is the listed applicant for CLEARARCH?

The FDA 510(k) record lists Ormco Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARARCH?

The FDA product code for CLEARARCH is DYW.

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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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