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FDA 510(k)

ETCHING GEL

K-Number: K810266 · 1981-02-23

ApplicantEspe-Premier Sales Co.
Decision Date1981-02-23
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETCHING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Espe-Premier Sales Co.. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K810266. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETCHING GEL?

ETCHING GEL is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is Espe-Premier Sales Co.. The 510(k) number is K810266.

When did ETCHING GEL receive FDA 510(k) clearance?

ETCHING GEL received FDA 510(k) clearance on 1981-02-23, under 510(k) number K810266.

Who is the listed applicant for ETCHING GEL?

The FDA 510(k) record lists Espe-Premier Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETCHING GEL?

The FDA product code for ETCHING GEL is EJK.

Related Clinical Trials

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Other records listing Espe-Premier Sales Co. 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.

K812116PERMAGUMK812117PERMAGUM ADHESIVEK812119NIMETIC-DISPERSK812115KETAC-CHEMK812118NIMETIC POLISHING PASTEK811624VISIO-SEAL

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Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

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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