FDA.reportPublic FDA data

510(k) K851045

Device
DENT-DR. VACU-FRAME
Applicant
DENT-DR.
510(k) number
K851045
Product code
EIE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-04-22
Date received
1985-03-14
Regulation
872.6300
Classification name
Dam, Rubber
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS M TYSSE
Address
2415 Pebble Brook SE Grand Rapids MI US 49506 49506

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182118armor LCMavrik Dental Systems, Ltd.2019-05-03
K151945Triumph Resin DamDenali Corporation2016-02-18
K050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.2005-03-04
K043301GC TION GINGIVAL PROTECTORGC America, Inc.2005-01-25
K040797BRITESMILE MASKING CREAMBritesmile, Inc.2004-04-02
K022522PULPDENT PUTTY DAMPulpdent Corporation2002-09-26
K021524LIGHT CURE DENTAL DAMPrime Dental Manufacturing, Inc.2002-07-19
K021613NIVEOUS LIQUID DAMShofu Dental Corp.2002-06-20
K010935BRITESMILE BARRIER MATERIALBritesmile, Inc.2001-09-05
K983227POWER BLOCKKreativ, Inc.1998-12-11
K972775FASTDAMInterdent, Inc.1998-02-27
K961472DENTAL DAM SILICONEWorldwide Dental, Inc.1996-08-07
K954990DENTAL DAMThe Hygenic Corp.1996-01-26
K952628ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMSElastomade Accessories Sdn Bhd1995-10-19
K942992ROYAL SHIELD RUBBER DAMSElastomade Accessories Sdn Bhd1994-09-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases