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FDA 510(k)

ORTHODONTIC ELASTOMERIC CHAIN

K-Number: K943420 · 1995-05-23

ApplicantJon-Ko Products, Inc.
Decision Date1995-05-23
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC ELASTOMERIC CHAIN is the device name listed in this FDA 510(k) record. The listed applicant is Jon-Ko Products, Inc.. It received FDA 510(k) clearance on 1995-05-23 under 510(k) number K943420. 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 ELASTOMERIC CHAIN?

ORTHODONTIC ELASTOMERIC CHAIN is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Jon-Ko Products, Inc.. The 510(k) number is K943420.

When did ORTHODONTIC ELASTOMERIC CHAIN receive FDA 510(k) clearance?

ORTHODONTIC ELASTOMERIC CHAIN received FDA 510(k) clearance on 1995-05-23, under 510(k) number K943420.

Who is the listed applicant for ORTHODONTIC ELASTOMERIC CHAIN?

The FDA 510(k) record lists Jon-Ko Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC ELASTOMERIC CHAIN?

The FDA product code for ORTHODONTIC ELASTOMERIC CHAIN 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 Jon-Ko Products, 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.

K943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEK943421ORTHODONITC ELASTOMERIC SLEEVINGK943417ORTHODONTIC ELASTOMERIC TUBE/THREADK943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULE

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.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, 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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