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FDA 510(k)

ORTHODONTIC ELASTICS BANDS

K-Number: K920645 · 1992-07-28

ApplicantMasel Industries, Inc.
Decision Date1992-07-28
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC ELASTICS BANDS is the device name listed in this FDA 510(k) record. The listed applicant is Masel Industries, Inc.. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K920645. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC ELASTICS BANDS?

ORTHODONTIC ELASTICS BANDS is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Masel Industries, Inc.. The 510(k) number is K920645.

When did ORTHODONTIC ELASTICS BANDS receive FDA 510(k) clearance?

ORTHODONTIC ELASTICS BANDS received FDA 510(k) clearance on 1992-07-28, under 510(k) number K920645.

Who is the listed applicant for ORTHODONTIC ELASTICS BANDS?

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

What is the FDA product code for ORTHODONTIC ELASTICS BANDS?

The FDA product code for ORTHODONTIC ELASTICS BANDS is EJF.

Related Clinical Trials

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Other records listing Masel Industries, Inc. 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.

K911231ORTHODONTIC WIREK903498RETAINER, SCREW EXPANSION ORTHODONTICK902809BRACKET, METAL, ORTHODOTNIC

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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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