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FDA 510(k)

HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

K-Number: K991161 · 1999-04-29

ApplicantKay See Dental Mfg. Co.
Decision Date1999-04-29
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 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 1999-04-29 under 510(k) number K991161. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-CAST ACRYLIC VARNISH, MODEL 78125?

HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 is a medical device that received FDA 510(k) clearance on 1999-04-29. The listed applicant is Kay See Dental Mfg. Co.. The 510(k) number is K991161.

When did HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 receive FDA 510(k) clearance?

HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 received FDA 510(k) clearance on 1999-04-29, under 510(k) number K991161.

Who is the listed applicant for HYDRO-CAST ACRYLIC VARNISH, MODEL 78125?

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 ACRYLIC VARNISH, MODEL 78125?

The FDA product code for HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 is EIA.

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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 68400K990306HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025K990155HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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