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FDA 510(k)

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

K-Number: K992609 · 1999-09-22

ApplicantKay See Dental Mfg. Co.
Decision Date1999-09-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 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 1999-09-22 under 510(k) number K992609. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400?

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Kay See Dental Mfg. Co.. The 510(k) number is K992609.

When did HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 receive FDA 510(k) clearance?

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 received FDA 510(k) clearance on 1999-09-22, under 510(k) number K992609.

Who is the listed applicant for HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400?

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 SILICONE SOFT-LINER, MODEL 68400?

The FDA product code for HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 is EBI.

Related Clinical Trials

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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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 98250K991161HYDRO-CAST ACRYLIC VARNISH, MODEL 78125K990306HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025K990155HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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