VERSYO.DIRECT

Resin, Denture, Relining, Repairing, Rebasing

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Versyo.direct.

Pre-market Notification Details

Device IDK043295
510k NumberK043295
Device Name:VERSYO.DIRECT
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-29
Decision Date2005-01-05

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