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FDA 510(k)

ULTRATEMP FIRM, FAST AND REGULAR SET

K-Number: K080768 · 2008-04-11

ApplicantUltradent Products, Inc.
Decision Date2008-04-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRATEMP FIRM, FAST AND REGULAR SET is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2008-04-11 under 510(k) number K080768. 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 ULTRATEMP FIRM, FAST AND REGULAR SET?

ULTRATEMP FIRM, FAST AND REGULAR SET is a medical device that received FDA 510(k) clearance on 2008-04-11. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K080768.

When did ULTRATEMP FIRM, FAST AND REGULAR SET receive FDA 510(k) clearance?

ULTRATEMP FIRM, FAST AND REGULAR SET received FDA 510(k) clearance on 2008-04-11, under 510(k) number K080768.

Who is the listed applicant for ULTRATEMP FIRM, FAST AND REGULAR SET?

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

What is the FDA product code for ULTRATEMP FIRM, FAST AND REGULAR SET?

The FDA product code for ULTRATEMP FIRM, FAST AND REGULAR SET 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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