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FDA 510(k)

ETEN-GEL

K-Number: K852658 · 1985-07-24

ApplicantDentsply Intl.
Decision Date1985-07-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETEN-GEL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K852658. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEN-GEL?

ETEN-GEL is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Dentsply Intl.. The 510(k) number is K852658.

When did ETEN-GEL receive FDA 510(k) clearance?

ETEN-GEL received FDA 510(k) clearance on 1985-07-24, under 510(k) number K852658.

Who is the listed applicant for ETEN-GEL?

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

What is the FDA product code for ETEN-GEL?

The FDA product code for ETEN-GEL is EBF.

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Related Devices (Code: EBF)

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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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