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FDA 510(k)

ORTHODONTIC ELASTICS

K-Number: K810010 · 1981-01-28

ApplicantOrec Corp.
Decision Date1981-01-28
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC ELASTICS is the device name listed in this FDA 510(k) record. The listed applicant is Orec Corp.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K810010. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC ELASTICS?

ORTHODONTIC ELASTICS is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Orec Corp.. The 510(k) number is K810010.

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

ORTHODONTIC ELASTICS received FDA 510(k) clearance on 1981-01-28, under 510(k) number K810010.

Who is the listed applicant for ORTHODONTIC ELASTICS?

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

What is the FDA product code for ORTHODONTIC ELASTICS?

The FDA product code for ORTHODONTIC ELASTICS is ECI.

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 Orec Corp. 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.

K803316ORTHODONTIC BRACKET

Related Devices (Code: ECI)

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.

K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.K980053GLENROE CHAINGlenroe TechnologiesK973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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