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FDA 510(k)

TUFF-TEMP 2.0

K-Number: K120784 · 2012-06-08

ApplicantPulpdent Corporation
Decision Date2012-06-08
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TUFF-TEMP 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2012-06-08 under 510(k) number K120784. 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 TUFF-TEMP 2.0?

TUFF-TEMP 2.0 is a medical device that received FDA 510(k) clearance on 2012-06-08. The listed applicant is Pulpdent Corporation. The 510(k) number is K120784.

When did TUFF-TEMP 2.0 receive FDA 510(k) clearance?

TUFF-TEMP 2.0 received FDA 510(k) clearance on 2012-06-08, under 510(k) number K120784.

Who is the listed applicant for TUFF-TEMP 2.0?

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

What is the FDA product code for TUFF-TEMP 2.0?

The FDA product code for TUFF-TEMP 2.0 is EBG.

Other records listing Pulpdent Corporation 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.

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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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