4 ALL (DW286A)

Alloy, Metal, Base

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for 4 All (dw286a).

Pre-market Notification Details

Device IDK020253
510k NumberK020253
Device Name:4 ALL (DW286A)
ClassificationAlloy, Metal, Base
Applicant IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactAnderjeet Gulati
CorrespondentAnderjeet Gulati
IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEJH  
CFR Regulation Number872.3710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-24
Decision Date2002-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970553800215 K020253 000
06970553800055 K020253 000
06970553800062 K020253 000
06970553800079 K020253 000
06970553800086 K020253 000
06970553800109 K020253 000
06970553800116 K020253 000
06970553800123 K020253 000
06970553800130 K020253 000
06970553800147 K020253 000
06970553800154 K020253 000
06970553800161 K020253 000
06970553800178 K020253 000
06970553800185 K020253 000
06970553800192 K020253 000
06970553800208 K020253 000
06970553800003 K020253 000

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