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FDA 510(k)

TURBO TEMP 3

K-Number: K102753 · 2011-02-04

ApplicantDanville Materials, Inc.
Decision Date2011-02-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TURBO TEMP 3 is the device name listed in this FDA 510(k) record. The listed applicant is Danville Materials, Inc.. It received FDA 510(k) clearance on 2011-02-04 under 510(k) number K102753. 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 TURBO TEMP 3?

TURBO TEMP 3 is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Danville Materials, Inc.. The 510(k) number is K102753.

When did TURBO TEMP 3 receive FDA 510(k) clearance?

TURBO TEMP 3 received FDA 510(k) clearance on 2011-02-04, under 510(k) number K102753.

Who is the listed applicant for TURBO TEMP 3?

The FDA 510(k) record lists Danville Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURBO TEMP 3?

The FDA product code for TURBO TEMP 3 is EBG.

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Other records listing Danville Materials, 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.

K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDK111876Z BOND, PRELUDE ONEK110642SILJETR SYSTEMK092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387K090106PRELUDE ONE

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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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