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FDA 510(k)

REFURBISHED ORTHODONTIC APPLIANCES

K-Number: K913913 · 1991-11-27

ApplicantOrtho-Cycle Co.
Decision Date1991-11-27
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REFURBISHED ORTHODONTIC APPLIANCES is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Cycle Co.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K913913. 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 REFURBISHED ORTHODONTIC APPLIANCES?

REFURBISHED ORTHODONTIC APPLIANCES is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Ortho-Cycle Co.. The 510(k) number is K913913.

When did REFURBISHED ORTHODONTIC APPLIANCES receive FDA 510(k) clearance?

REFURBISHED ORTHODONTIC APPLIANCES received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913913.

Who is the listed applicant for REFURBISHED ORTHODONTIC APPLIANCES?

The FDA 510(k) record lists Ortho-Cycle Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFURBISHED ORTHODONTIC APPLIANCES?

The FDA product code for REFURBISHED ORTHODONTIC APPLIANCES 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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