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510(k) K904928

Device
PALAVIT GLC
Applicant
KULZER, INC.
510(k) number
K904928
Product code
EGD  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-06
Date received
1990-10-31
Regulation
872.6890
Classification name
Wax, Dental, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SHARON PARKER
Address
10005 Muirlands Blvd. Unit G. Irvine CA US 92718 92718

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EGD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020009BRACE EZEUdent, Inc.2002-02-11
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
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

Legacy Summary#

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FDA Review#

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