FDA.reportPublic FDA data

510(k) K901097

Device
FILLOCK REAMER
Applicant
IVOCLAR NORTH AMERICA, INC.
510(k) number
K901097
Product code
DZA  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-25
Date received
1990-03-07
Regulation
872.4130
Classification name
Drill, Dental, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
L SEVERANCE,DDS
Address
175 Pineview Dr. Amherst NY US 14228 14228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DZA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984508SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MODW&H Dentalwerk Buermoos GmbH1999-06-25
K962979S-53 INTRORAL DENTAL SYSTEMDel Medical Systems Corp.1996-09-25
K954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSTulsa Dental Products, Ltd.1996-01-16
K914724ADA SHANK EXTENSIONImplant Corp. of America1993-07-27
K905418GATES GLIDDEN DRILLSThe Hygenic Corp.1991-07-25
K896149ANEST-EZE DENTAL DRILL RA#2Signature One Products, Inc.1990-01-19
K884187INDENTEC DRILL RA #1Phillip C. Crawford, D.D.S.1988-12-22
K811113RIESS-LUHRAllomedic1981-06-16
K801887DRILL, DENTALAesculap Instruments Corp.1980-08-20
K801888HANDPIECE, DENTALAesculap Instruments Corp.1980-08-20
K761275AIROTOS LF HANDPIECEDentsply Intl.1976-12-23
K760956SURGICAL MICRO DRILLAmerican Safety Equipment Corp.1976-11-19

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