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FDA 510(k)

TOTAL ETCH GEL

K-Number: K945769 · 1994-12-29

ApplicantDentsply Intl.
Decision Date1994-12-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOTAL ETCH 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 1994-12-29 under 510(k) number K945769. 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 TOTAL ETCH GEL?

TOTAL ETCH GEL is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Dentsply Intl.. The 510(k) number is K945769.

When did TOTAL ETCH GEL receive FDA 510(k) clearance?

TOTAL ETCH GEL received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945769.

Who is the listed applicant for TOTAL ETCH 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 TOTAL ETCH GEL?

The FDA product code for TOTAL ETCH GEL is EBF.

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Related Devices (Code: EBF)

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.

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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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