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FDA 510(k)

TEMPFX ESTHETIC PROVISIONAL SYSTEM

K-Number: K061264 · 2006-05-23

ApplicantDentsply International, Inc.
Decision Date2006-05-23
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPFX ESTHETIC PROVISIONAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2006-05-23 under 510(k) number K061264. 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 TEMPFX ESTHETIC PROVISIONAL SYSTEM?

TEMPFX ESTHETIC PROVISIONAL SYSTEM is a medical device that received FDA 510(k) clearance on 2006-05-23. The listed applicant is Dentsply International, Inc.. The 510(k) number is K061264.

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

TEMPFX ESTHETIC PROVISIONAL SYSTEM received FDA 510(k) clearance on 2006-05-23, under 510(k) number K061264.

Who is the listed applicant for TEMPFX ESTHETIC PROVISIONAL SYSTEM?

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

What is the FDA product code for TEMPFX ESTHETIC PROVISIONAL SYSTEM?

The FDA product code for TEMPFX ESTHETIC PROVISIONAL SYSTEM is EBG.

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Related Devices (Code: EBG)

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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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