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FDA 510(k)

CERAM-ETCH

K-Number: K854494 · 1985-12-23

ApplicantGresco Products, Inc.
Decision Date1985-12-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAM-ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Gresco Products, Inc.. It received FDA 510(k) clearance on 1985-12-23 under 510(k) number K854494. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAM-ETCH?

CERAM-ETCH is a medical device that received FDA 510(k) clearance on 1985-12-23. The listed applicant is Gresco Products, Inc.. The 510(k) number is K854494.

When did CERAM-ETCH receive FDA 510(k) clearance?

CERAM-ETCH received FDA 510(k) clearance on 1985-12-23, under 510(k) number K854494.

Who is the listed applicant for CERAM-ETCH?

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

What is the FDA product code for CERAM-ETCH?

The FDA product code for CERAM-ETCH is EBC.

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Other records listing Gresco Products, Inc. as applicant

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.

K981524PRILANEK913405KAR-D-TEKK910813MET-ETCHK910803ENAMEL ETCHING GELK901973CP-3 DENTAL POLISHING MATERIALK854495GRESCO N.P. DENTAL ALLOY

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Related Devices (Code: EBC)

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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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