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FDA 510(k)

HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250

K-Number: K001309 · 2000-06-13

ApplicantKay See Dental Mfg. Co.
Decision Date2000-06-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 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 2000-06-13 under 510(k) number K001309. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250?

HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 is a medical device that received FDA 510(k) clearance on 2000-06-13. The listed applicant is Kay See Dental Mfg. Co.. The 510(k) number is K001309.

When did HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 receive FDA 510(k) clearance?

HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 received FDA 510(k) clearance on 2000-06-13, under 510(k) number K001309.

Who is the listed applicant for HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250?

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 BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250?

The FDA product code for HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 is EBG.

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.

K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400K991161HYDRO-CAST ACRYLIC VARNISH, MODEL 78125K990306HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025K990155HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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