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FDA 510(k)

ORTHODONTIC BRACES

K-Number: K981433 · 1998-06-25

ApplicantMidwest Orthodontic Mfg.
Decision Date1998-06-25
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC BRACES is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Orthodontic Mfg.. It received FDA 510(k) clearance on 1998-06-25 under 510(k) number K981433. 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 ORTHODONTIC BRACES?

ORTHODONTIC BRACES is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Midwest Orthodontic Mfg.. The 510(k) number is K981433.

When did ORTHODONTIC BRACES receive FDA 510(k) clearance?

ORTHODONTIC BRACES received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981433.

Who is the listed applicant for ORTHODONTIC BRACES?

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

What is the FDA product code for ORTHODONTIC BRACES?

The FDA product code for ORTHODONTIC BRACES is DYW.

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Other records listing Midwest Orthodontic Mfg. 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.

K955740GLUFLORMAK952856LIGHT-CURE PCK952855PC-LOCKK952858LIGHT-CUREK952857PRO-LOCKK900824FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)

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Related Devices (Code: DYW)

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.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.

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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