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FDA 510(k)

ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN

K-Number: K921283 · 1992-12-23

ApplicantJeneric/Pentron, Inc.
Decision Date1992-12-23
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K921283. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN?

ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K921283.

When did ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN receive FDA 510(k) clearance?

ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN received FDA 510(k) clearance on 1992-12-23, under 510(k) number K921283.

Who is the listed applicant for ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN?

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

What is the FDA product code for ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN?

The FDA product code for ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN is DYH.

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Other records listing Jeneric/Pentron, Inc. as applicant

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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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