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FDA 510(k)

GENTEEL

K-Number: K863676 · 1986-10-02

ApplicantLuben Dental Co., Inc.
Decision Date1986-10-02
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENTEEL is the device name listed in this FDA 510(k) record. The listed applicant is Luben Dental Co., Inc.. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863676. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTEEL?

GENTEEL is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Luben Dental Co., Inc.. The 510(k) number is K863676.

When did GENTEEL receive FDA 510(k) clearance?

GENTEEL received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863676.

Who is the listed applicant for GENTEEL?

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

What is the FDA product code for GENTEEL?

The FDA product code for GENTEEL is ELC.

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Related Devices (Code: ELC)

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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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