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FDA 510(k)

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S

K-Number: K120378 · 2012-03-30

ApplicantKuraray Medical, Inc.
Decision Date2012-03-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2012-03-30 under 510(k) number K120378. 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 PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S?

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S is a medical device that received FDA 510(k) clearance on 2012-03-30. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K120378.

When did PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S receive FDA 510(k) clearance?

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S received FDA 510(k) clearance on 2012-03-30, under 510(k) number K120378.

Who is the listed applicant for PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S?

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

What is the FDA product code for PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S?

The FDA product code for PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S is EMA.

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Other records listing Kuraray Medical, Inc. as applicant

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.

K120379PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA SK111975CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACKK100328CLEARFIL MAJETY POSTERIORK092281CLEARFIL MAJESTY POSTERIOR PLTK081583CLEARFIL SA CEMENTK071169CLEARFIL MAJESTY POSTERIOR PLT

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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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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