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FDA 510(k)

COOL TEMP NATURAL

K-Number: K041098 · 2004-05-13

ApplicantColtene AG
Decision Date2004-05-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COOL TEMP NATURAL is the device name listed in this FDA 510(k) record. The listed applicant is Coltene AG. It received FDA 510(k) clearance on 2004-05-13 under 510(k) number K041098. 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 COOL TEMP NATURAL?

COOL TEMP NATURAL is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Coltene AG. The 510(k) number is K041098.

When did COOL TEMP NATURAL receive FDA 510(k) clearance?

COOL TEMP NATURAL received FDA 510(k) clearance on 2004-05-13, under 510(k) number K041098.

Who is the listed applicant for COOL TEMP NATURAL?

The FDA 510(k) record lists Coltene AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOL TEMP NATURAL?

The FDA product code for COOL TEMP NATURAL 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 Coltene AG 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.

K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM

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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