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FDA 510(k)

POWER COINS GLOW IN THE DARK LIGATURES

K-Number: K980864 · 1998-04-20

ApplicantOrtho Kinetics Corp.
Decision Date1998-04-20
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWER COINS GLOW IN THE DARK LIGATURES is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Kinetics Corp.. It received FDA 510(k) clearance on 1998-04-20 under 510(k) number K980864. 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 POWER COINS GLOW IN THE DARK LIGATURES?

POWER COINS GLOW IN THE DARK LIGATURES is a medical device that received FDA 510(k) clearance on 1998-04-20. The listed applicant is Ortho Kinetics Corp.. The 510(k) number is K980864.

When did POWER COINS GLOW IN THE DARK LIGATURES receive FDA 510(k) clearance?

POWER COINS GLOW IN THE DARK LIGATURES received FDA 510(k) clearance on 1998-04-20, under 510(k) number K980864.

Who is the listed applicant for POWER COINS GLOW IN THE DARK LIGATURES?

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

What is the FDA product code for POWER COINS GLOW IN THE DARK LIGATURES?

The FDA product code for POWER COINS GLOW IN THE DARK LIGATURES is ECI.

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Other records listing Ortho Kinetics Corp. as applicant

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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.

K980053GLENROE CHAINGlenroe TechnologiesK973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-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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