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FDA 510(k)

ZENITH TOTAL ETCH 10% PHOSPHORIC ACID

K-Number: K935032 · 1994-01-18

ApplicantForemost Dental Mfg., Inc.
Decision Date1994-01-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENITH TOTAL ETCH 10% PHOSPHORIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Foremost Dental Mfg., Inc.. It received FDA 510(k) clearance on 1994-01-18 under 510(k) number K935032. 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 ZENITH TOTAL ETCH 10% PHOSPHORIC ACID?

ZENITH TOTAL ETCH 10% PHOSPHORIC ACID is a medical device that received FDA 510(k) clearance on 1994-01-18. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K935032.

When did ZENITH TOTAL ETCH 10% PHOSPHORIC ACID receive FDA 510(k) clearance?

ZENITH TOTAL ETCH 10% PHOSPHORIC ACID received FDA 510(k) clearance on 1994-01-18, under 510(k) number K935032.

Who is the listed applicant for ZENITH TOTAL ETCH 10% PHOSPHORIC ACID?

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

What is the FDA product code for ZENITH TOTAL ETCH 10% PHOSPHORIC ACID?

The FDA product code for ZENITH TOTAL ETCH 10% PHOSPHORIC ACID 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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