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FDA 510(k)

J1 ATTACHMENT (ORTHODONTIC APPLIANCE)

K-Number: K891982 · 1989-07-14

ApplicantT.M.K. Dental Products
Decision Date1989-07-14
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

J1 ATTACHMENT (ORTHODONTIC APPLIANCE) is the device name listed in this FDA 510(k) record. The listed applicant is T.M.K. Dental Products. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K891982. 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 J1 ATTACHMENT (ORTHODONTIC APPLIANCE)?

J1 ATTACHMENT (ORTHODONTIC APPLIANCE) is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is T.M.K. Dental Products. The 510(k) number is K891982.

When did J1 ATTACHMENT (ORTHODONTIC APPLIANCE) receive FDA 510(k) clearance?

J1 ATTACHMENT (ORTHODONTIC APPLIANCE) received FDA 510(k) clearance on 1989-07-14, under 510(k) number K891982.

Who is the listed applicant for J1 ATTACHMENT (ORTHODONTIC APPLIANCE)?

The FDA 510(k) record lists T.M.K. Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J1 ATTACHMENT (ORTHODONTIC APPLIANCE)?

The FDA product code for J1 ATTACHMENT (ORTHODONTIC APPLIANCE) 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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