IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF

Agent, Tooth Bonding, Resin

HERAEUS KULZER, LLC

The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self.

Pre-market Notification Details

Device IDK123278
510k NumberK123278
Device Name:IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
ClassificationAgent, Tooth Bonding, Resin
Applicant HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
ContactJamie Mearna
CorrespondentJamie Mearna
HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-22
Decision Date2012-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660482610 K123278 000
J014660462450 K123278 000
J014660462440 K123278 000
J014660462430 K123278 000

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