FDA.reportPublic FDA data

510(k) K761331

Device
OPUS I OPTION - FIBER OPTIC L SYSTEM
Applicant
Syntex Corp.
510(k) number
K761331
Product code
EAY
Decision
Substantially Equivalent (SESE)
Decision date
1977-01-03
Date received
1976-12-27
Regulation
872.4620
Classification name
Light, Fiber Optic, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953192MODEL A15-103Beaverstate Dental, Inc.1995-09-05
K953191MODEL A15-101Beaverstate Dental, Inc.1995-09-05
K935718JEDENTAL VLC DENTAL CURING LIGHTJedental Co., Inc.1994-01-26
K871816STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TMStryker Corp.1987-08-03
K831976POWER OPTICRitter Co.1983-08-12
K831824DENTAL ELECTRONIC/S.B.R TRADING BU HANDSilverman'S1983-08-11
K820907DENTISCOPEChayes Virginia, Inc.1982-05-05
K812605FIBER OPTIC LIGHT SOURCE IVenture Technology, Inc.1981-10-02
K802684HELIOMATVivadent (Usa), Inc.1980-11-24
K802716DEN-MAT FIBER OPTIC HALOGEN LIGHTDen-Mat Corp.1980-11-12
K801592FIBER OPTIC HOSELares Manufacturing Co., Inc.1980-07-21
K801591FIBER OPTIC ILLUMINATORLares Manufacturing Co., Inc.1980-07-21
K791771ORALUMINATOR III AUTO-LIGHTMidwest1979-11-20
K791733LIGHT-PAKMidwest1979-10-23
K781878LIGHT, INSIDEMidwest1978-12-29