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FDA 510(k)

DENT-O-CRYL ORTHODONTIC ACRYLIC

K-Number: K942667 · 1995-02-13

ApplicantDentauraum, Inc.
Decision Date1995-02-13
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENT-O-CRYL ORTHODONTIC ACRYLIC is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K942667. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENT-O-CRYL ORTHODONTIC ACRYLIC?

DENT-O-CRYL ORTHODONTIC ACRYLIC is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Dentauraum, Inc.. The 510(k) number is K942667.

When did DENT-O-CRYL ORTHODONTIC ACRYLIC receive FDA 510(k) clearance?

DENT-O-CRYL ORTHODONTIC ACRYLIC received FDA 510(k) clearance on 1995-02-13, under 510(k) number K942667.

Who is the listed applicant for DENT-O-CRYL ORTHODONTIC ACRYLIC?

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

What is the FDA product code for DENT-O-CRYL ORTHODONTIC ACRYLIC?

The FDA product code for DENT-O-CRYL ORTHODONTIC ACRYLIC is KMY.

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Other records listing Dentauraum, 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.

K952867REMANIUM:GM 700, GM 380, GM 800, GFHK952866REMATITAN TITANIUMK952870REMANIUM: CS & G-SOFTK952865REMANIUM: 200,CS, 380, AND CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942666ORTHALGENAT IMPRESSION MATERIAL

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Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics

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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