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FDA 510(k)

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM

K-Number: K080311 · 2008-04-18

ApplicantDentsply Interntional
Decision Date2008-04-18
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2008-04-18 under 510(k) number K080311. 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 MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM?

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-18. The listed applicant is Dentsply Interntional. The 510(k) number is K080311.

When did MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM receive FDA 510(k) clearance?

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM received FDA 510(k) clearance on 2008-04-18, under 510(k) number K080311.

Who is the listed applicant for MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM?

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

What is the FDA product code for MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM?

The FDA product code for MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM is EBG.

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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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