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510(k) K854530

Device
Premium Flexi-tough
Applicant
THE HYGENIC CORP.
510(k) number
K854530
Product code
EGD
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-04
Date received
1985-11-13
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
MEYER
Address
1245 Home Ave. Akron OH US 44310 44310

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
K904928PALAVIT GLCKulzer, Inc.1991-06-06
K895562PEMACO 2000 INTRAORAL DENTAL WAXPemaco, Inc.1989-11-06
K895566PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFTPemaco, Inc.1989-11-06
K895564PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARDPemaco, Inc.1989-11-06
K895563PEMACO BITE WAX SHEETSPemaco, Inc.1989-11-06
K895561PEMACO 3000 INTRAORAL DENTAL WAXPemaco, Inc.1989-11-06
K895565PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARDPemaco, Inc.1989-10-24