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FDA 510(k)

TEMPOSIL 2

K-Number: K083304 · 2009-02-06

ApplicantColtene/Whaledent AG
Decision Date2009-02-06
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPOSIL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K083304. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPOSIL 2?

TEMPOSIL 2 is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K083304.

When did TEMPOSIL 2 receive FDA 510(k) clearance?

TEMPOSIL 2 received FDA 510(k) clearance on 2009-02-06, under 510(k) number K083304.

Who is the listed applicant for TEMPOSIL 2?

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

What is the FDA product code for TEMPOSIL 2?

The FDA product code for TEMPOSIL 2 is EMA.

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Related Devices (Code: EMA)

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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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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