FDA.reportPublic FDA data

510(k) K020009

Device
BRACE EZE
Applicant
Udent, Inc.
510(k) number
K020009
Product code
EGD
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-11
Date received
2002-01-02
Regulation
872.6890
Classification name
Wax, Dental, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MANAR JAMAL
Address
676 Fairplex Dr. Pomona CA US 91768 91768

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EGD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945535GLENROE ORTHO-SILGlenroe Technologies1995-01-27
K924024ORTHO WAXHeraeus Kulzer, Inc.1992-11-17
K923586BURNOUT MATERIALDentsply Intl.1992-09-29
K914892SALIVA-STIMOrion Diagnostica, Inc.1992-09-02
K922380BITE RIM WAXDentsply Intl.1992-06-16
K914513PALAVIT GHeraeus Kulzer, Inc.1992-03-19
K910676INTRAORAL DENTAL WAXPemaco, Inc.1991-08-21
K904928PALAVIT GLCKulzer, Inc.1991-06-06
K895561PEMACO 3000 INTRAORAL DENTAL WAXPemaco, Inc.1989-11-06
K895562PEMACO 2000 INTRAORAL DENTAL WAXPemaco, Inc.1989-11-06
K895563PEMACO BITE WAX SHEETSPemaco, Inc.1989-11-06
K895564PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARDPemaco, Inc.1989-11-06
K895566PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFTPemaco, Inc.1989-11-06
K895565PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARDPemaco, Inc.1989-10-24
K880607UTILITY WAX STRIPS, SPEARMINTColumbus Dental Mfg. Co.1988-03-31