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FDA 510(k)

ADJUSTABLE BITE CORRECTOR

K-Number: K942492 · 1994-07-13

ApplicantOrthoplus, Inc.
Decision Date1994-07-13
Product CodeECO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADJUSTABLE BITE CORRECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthoplus, Inc.. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K942492. The device is classified under product code ECO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADJUSTABLE BITE CORRECTOR?

ADJUSTABLE BITE CORRECTOR is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Orthoplus, Inc.. The 510(k) number is K942492.

When did ADJUSTABLE BITE CORRECTOR receive FDA 510(k) clearance?

ADJUSTABLE BITE CORRECTOR received FDA 510(k) clearance on 1994-07-13, under 510(k) number K942492.

Who is the listed applicant for ADJUSTABLE BITE CORRECTOR?

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

What is the FDA product code for ADJUSTABLE BITE CORRECTOR?

The FDA product code for ADJUSTABLE BITE CORRECTOR is ECO.

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Related Devices (Code: ECO)

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.

K943068MAGNEFORCEOrmco Corp.K933542MESIAL LOOP BARGac Intl., Inc.K844234ACTIVE VERTICAL CORRECTOR APPLIANCEActive Vertical Correctors, Inc.K843550ORTHOMAG MAGNETIC FORCE SYSTEMMedical Magnetics, Inc.K843344ACTIVE VERTICAL CORRECTOR ACTIVE BITEActive Vertical Correctors, Inc.K770558ISODYNEHmw Industries

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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