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FDA 510(k)

PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE

K-Number: K912171 · 1991-08-13

ApplicantJack James
Decision Date1991-08-13
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Jack James. It received FDA 510(k) clearance on 1991-08-13 under 510(k) number K912171. 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 PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE?

PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE is a medical device that received FDA 510(k) clearance on 1991-08-13. The listed applicant is Jack James. The 510(k) number is K912171.

When did PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE receive FDA 510(k) clearance?

PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE received FDA 510(k) clearance on 1991-08-13, under 510(k) number K912171.

Who is the listed applicant for PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE?

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

What is the FDA product code for PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE?

The FDA product code for PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE is EJF.

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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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