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FDA 510(k)

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

K-Number: K973495 · 1997-12-01

ApplicantGlenroe
Decision Date1997-12-01
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES is the device name listed in this FDA 510(k) record. The listed applicant is Glenroe. It received FDA 510(k) clearance on 1997-12-01 under 510(k) number K973495. 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 GLENROE GLOW IN DARK ELASTOMERIC LIGATURES?

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is Glenroe. The 510(k) number is K973495.

When did GLENROE GLOW IN DARK ELASTOMERIC LIGATURES receive FDA 510(k) clearance?

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES received FDA 510(k) clearance on 1997-12-01, under 510(k) number K973495.

Who is the listed applicant for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES?

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

What is the FDA product code for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES?

The FDA product code for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES is ECI.

Related Clinical Trials

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Other records listing Glenroe 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.

K923124GLENROE GOLDEN ORTHODONTIC 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 TechnologiesK943419ORTHODONTIC 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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