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FDA 510(k)

SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE

K-Number: K110796 · 2011-03-31

ApplicantBiomers Products, LLC
Decision Date2011-03-31
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Biomers Products, LLC. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K110796. 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 SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE?

SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Biomers Products, LLC. The 510(k) number is K110796.

When did SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE receive FDA 510(k) clearance?

SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE received FDA 510(k) clearance on 2011-03-31, under 510(k) number K110796.

Who is the listed applicant for SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE?

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

What is the FDA product code for SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE?

The FDA product code for SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE is DYW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Biomers Products, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101481BIOMERS TRANSLUCENT ORTHODONTIC BRACKET

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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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