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FDA 510(k)

ORTHODONTIC ELASTOMER

K-Number: K932319 · 1993-09-20

ApplicantGac Intl., Inc.
Decision Date1993-09-20
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC ELASTOMER is the device name listed in this FDA 510(k) record. The listed applicant is Gac Intl., Inc.. It received FDA 510(k) clearance on 1993-09-20 under 510(k) number K932319. 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 ELASTOMER?

ORTHODONTIC ELASTOMER is a medical device that received FDA 510(k) clearance on 1993-09-20. The listed applicant is Gac Intl., Inc.. The 510(k) number is K932319.

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

ORTHODONTIC ELASTOMER received FDA 510(k) clearance on 1993-09-20, under 510(k) number K932319.

Who is the listed applicant for ORTHODONTIC ELASTOMER?

The FDA 510(k) record lists Gac Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC ELASTOMER?

The FDA product code for ORTHODONTIC ELASTOMER is ECI.

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Other records listing Gac Intl., 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.

K981036SMARTBONDK942826ORTHODONITC METAL REINFORCED PLASTIC BRACKETK933542MESIAL LOOP BARK932825MICROARCH GOLD BRACKETK932025ION-IMPLANTED NEO SENTALLOYK920905BIOFORCE WIRE

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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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