HEMA-BENZ

Agent, Tooth Bonding, Resin

HEALTH-DENT INTL., INC.

The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Hema-benz.

Pre-market Notification Details

Device IDK953405
510k NumberK953405
Device Name:HEMA-BENZ
ClassificationAgent, Tooth Bonding, Resin
Applicant HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake,  IL  60164
ContactAl Bevilacqua
CorrespondentAl Bevilacqua
HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake,  IL  60164
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-20
Decision Date1995-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850362007076 K953405 000
00850362007069 K953405 000
00850362007052 K953405 000

Trademark Results [HEMA-BENZ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMA-BENZ
HEMA-BENZ
77396528 3501609 Live/Registered
HEALTHDENT'L LLC
2008-02-13
HEMA-BENZ
HEMA-BENZ
75123608 2057465 Dead/Cancelled
Health-Dent International, Inc.
1996-06-21

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