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FDA 510(k)

TEMPOCEM

K-Number: K110759 · 2011-06-10

ApplicantDmg USA, Inc.
Decision Date2011-06-10
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPOCEM is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K110759. The device is classified under product code EMB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPOCEM?

TEMPOCEM is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Dmg USA, Inc.. The 510(k) number is K110759.

When did TEMPOCEM receive FDA 510(k) clearance?

TEMPOCEM received FDA 510(k) clearance on 2011-06-10, under 510(k) number K110759.

Who is the listed applicant for TEMPOCEM?

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

What is the FDA product code for TEMPOCEM?

The FDA product code for TEMPOCEM is EMB.

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Other records listing Dmg USA, Inc. as applicant

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K171772Ecosite Bulk FillK160443TempoCem ClearK102603SA FLOWABLE ADHESIVEK101710LUXATEMP ULTRA /STARK100062INFILTRATION KITK093338SELF ADHESIVE COMPOSITE LUTING CEMENT

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Related Devices (Code: EMB)

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.

K161630Provicol QM PlusVoco GmbHK120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.K073539PROVISA CEMCavex Holland BVK020158NON-EUGENOL TEMPORARY CEMENTJ. Morita USA, Inc.K941066DENTAL 911L.A.F. Industries, Inc.K861681DENTIMEDIC DENTAL EMERGENCY KITDentimedic

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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