VENUS PEARL PLT REFILL A1

Material, Tooth Shade, Resin

HERAEUS KULZER, LLC

The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Venus Pearl Plt Refill A1.

Pre-market Notification Details

Device IDK112501
510k NumberK112501
Device Name:VENUS PEARL PLT REFILL A1
ClassificationMaterial, Tooth Shade, Resin
Applicant HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
ContactCheryl Zimmerman
CorrespondentCheryl Zimmerman
HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-30
Decision Date2011-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660982760 K112501 000
J014660481930 K112501 000
J014660481920 K112501 000
J014660481840 K112501 000
J014660481830 K112501 000
J014660481820 K112501 000
J014660481800 K112501 000
J014660481770 K112501 000
J014660481730 K112501 000
J014660481940 K112501 000
J014660481980 K112501 000
J014660481500 K112501 000
J014660481460 K112501 000
J014660481430 K112501 000
J014660481420 K112501 000
J014660481000 K112501 000
J014660480990 K112501 000
J014660480980 K112501 000
J014660481990 K112501 000
J014660481710 K112501 000
J014660481630 K112501 000
J014660818370 K112501 000
J014660818360 K112501 000
J014660982670 K112501 000
J014660982660 K112501 000
J014660982630 K112501 000
J014660982620 K112501 000
J014660968780 K112501 000
J014660982780 K112501 000
J014660480900 K112501 000
J014660480930 K112501 000
J014660481490 K112501 000
J014660481480 K112501 000
J014660481470 K112501 000
J014660481440 K112501 000
J014660481410 K112501 000
J014660480970 K112501 000
J014660480960 K112501 000
J014660480940 K112501 000
J014660481610 K112501 000
J014660481620 K112501 000
J014660968770 K112501 000
J014660968760 K112501 000
J014660968750 K112501 000
J014660968740 K112501 000
J014660968730 K112501 000
J014660968720 K112501 000
J014660968710 K112501 000
J014660968700 K112501 000
J014660968790 K112501 000
J014660968800 K112501 000
J014660818460 K112501 000
J014660818410 K112501 000
J01466081840 K112501 000
J014660818371 K112501 000
J014660818361 K112501 000
J014660968830 K112501 000
J014660968820 K112501 000
J014660968810 K112501 000
J014660968690 K112501 000
J014660968680 K112501 000
J014660481810 K112501 000
J014660481790 K112501 000
J014660481780 K112501 000
J014660481760 K112501 000
J014660481750 K112501 000
J014660481720 K112501 000
J014660481650 K112501 000
J014660481640 K112501 000
J014660481860 K112501 000
J014660481880 K112501 000
J014660968670 K112501 000
J014660482010 K112501 000
J014660482000 K112501 000
J014660481970 K112501 000
J014660481960 K112501 000
J014660481950 K112501 000
J014660481910 K112501 000
J014660481900 K112501 000
J014660818470 K112501 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.