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510(k) K833039

Device
HANDY IIM
Applicant
SHOFU DENTAL CORP.
510(k) number
K833039
Product code
EJP  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-04
Date received
1983-09-06
Regulation
872.3150
Classification name
Articulators
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

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 EJP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K926190ALRAND INC. (DENTAL HAND INSTRUMENTS)Alrand, Inc.1994-01-18
K896131GNATHOMAT ARTICULATORIvoclar North America, Inc.1989-12-04
K892373DENTAL PLASTIC BITE FORKTexapol Corp.1989-06-12
K884418PREMIER DIE-TRAK ARTICULATORPremier Medical1988-11-14
K872943DISPOSABLE ARTICULATORDentsply Intl.1987-08-11
K863009GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEXSds Dental, Inc.1986-09-25
K854702PLASTIC MOUNTING RINGSAlmore Intl., Inc.1986-03-06
K811075BALANCE ARTICULATORAlmore Intl., Inc.1981-05-13
K810971THE GNATOMETBauer, Cheng & Associates, Inc.1981-05-05
K801342DISPOSABLE ARTICULATORWilliams Gold Refining Co., Inc.1980-07-08

Legacy Summary#

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FDA Review#

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