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FDA 510(k)

RETAINER, SCREW EXPANSION ORTHODONTIC

K-Number: K903498 · 1991-03-12

ApplicantMasel Industries, Inc.
Decision Date1991-03-12
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RETAINER, SCREW EXPANSION ORTHODONTIC 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 1991-03-12 under 510(k) number K903498. 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 RETAINER, SCREW EXPANSION ORTHODONTIC?

RETAINER, SCREW EXPANSION ORTHODONTIC is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Masel Industries, Inc.. The 510(k) number is K903498.

When did RETAINER, SCREW EXPANSION ORTHODONTIC receive FDA 510(k) clearance?

RETAINER, SCREW EXPANSION ORTHODONTIC received FDA 510(k) clearance on 1991-03-12, under 510(k) number K903498.

Who is the listed applicant for RETAINER, SCREW EXPANSION ORTHODONTIC?

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 RETAINER, SCREW EXPANSION ORTHODONTIC?

The FDA product code for RETAINER, SCREW EXPANSION ORTHODONTIC is EJF.

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 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.

K920645ORTHODONTIC ELASTICS BANDSK911231ORTHODONTIC WIREK902809BRACKET, 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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