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FDA 510(k)

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025

K-Number: K990306 · 1999-03-03

ApplicantKay See Dental Mfg. Co.
Decision Date1999-03-03
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 is the device name listed in this FDA 510(k) record. The listed applicant is Kay See Dental Mfg. Co.. It received FDA 510(k) clearance on 1999-03-03 under 510(k) number K990306. 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 HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 is a medical device that received FDA 510(k) clearance on 1999-03-03. The listed applicant is Kay See Dental Mfg. Co.. The 510(k) number is K990306.

When did HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 receive FDA 510(k) clearance?

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 received FDA 510(k) clearance on 1999-03-03, under 510(k) number K990306.

Who is the listed applicant for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

The FDA 510(k) record lists Kay See Dental Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

The FDA product code for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 is EBC.

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Other records listing Kay See Dental Mfg. 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.

K001309HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400K991161HYDRO-CAST ACRYLIC VARNISH, MODEL 78125K990155HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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