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

Cement, Dental

KURARAY MEDICAL INC.

The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Panavia Sa Cement Automix Value Pack (universal (a2), White) Panavia Sa Cement Automix (universal (a2), White) Panavia S.

Pre-market Notification Details

Device IDK120379
510k NumberK120379
Device Name:PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
ClassificationCement, Dental
Applicant KURARAY MEDICAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku,  JP 100-0004
ContactMichio Takigawa
CorrespondentMichio Takigawa
KURARAY MEDICAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku,  JP 100-0004
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-07
Decision Date2012-03-30
Summary:summary

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