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FDA 510(k)

DENT-TEMP ACRYLIC

K-Number: K972198 · 1997-12-17

ApplicantHealth-Dent Intl., Inc.
Decision Date1997-12-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENT-TEMP ACRYLIC is the device name listed in this FDA 510(k) record. The listed applicant is Health-Dent Intl., Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K972198. 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 DENT-TEMP ACRYLIC?

DENT-TEMP ACRYLIC is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Health-Dent Intl., Inc.. The 510(k) number is K972198.

When did DENT-TEMP ACRYLIC receive FDA 510(k) clearance?

DENT-TEMP ACRYLIC received FDA 510(k) clearance on 1997-12-17, under 510(k) number K972198.

Who is the listed applicant for DENT-TEMP ACRYLIC?

The FDA 510(k) record lists Health-Dent Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENT-TEMP ACRYLIC?

The FDA product code for DENT-TEMP ACRYLIC is EBG.

Related Clinical Trials

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Other records listing Health-Dent Intl., Inc. 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.

K953405HEMA-BENZK951220HEMA-GLUK951380VILA PCK951381VILAK951235GIROCK951236PRO-LOCK

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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

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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