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FDA 510(k)

TEMPORARY COLD.V AND SELF-CURE DENTINE

K-Number: K082700 · 2008-12-09

ApplicantMajor Prodotti Dentari S.P.A.
Decision Date2008-12-09
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPORARY COLD.V AND SELF-CURE DENTINE is the device name listed in this FDA 510(k) record. The listed applicant is Major Prodotti Dentari S.P.A.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K082700. 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 TEMPORARY COLD.V AND SELF-CURE DENTINE?

TEMPORARY COLD.V AND SELF-CURE DENTINE is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Major Prodotti Dentari S.P.A.. The 510(k) number is K082700.

When did TEMPORARY COLD.V AND SELF-CURE DENTINE receive FDA 510(k) clearance?

TEMPORARY COLD.V AND SELF-CURE DENTINE received FDA 510(k) clearance on 2008-12-09, under 510(k) number K082700.

Who is the listed applicant for TEMPORARY COLD.V AND SELF-CURE DENTINE?

The FDA 510(k) record lists Major Prodotti Dentari S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPORARY COLD.V AND SELF-CURE DENTINE?

The FDA product code for TEMPORARY COLD.V AND SELF-CURE DENTINE 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 Major Prodotti Dentari S.P.A. 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.

K082153MAJOR.REPAIRK081884MAJOR.BASE 20

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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