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510(k) K940165

Device
ALASTIK
Applicant
Unitek Corp.
510(k) number
K940165
Product code
ECI
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-07
Date received
1994-01-06
Regulation
872.5410
Classification name
Band, Elastic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
MARLYN SCHEFF
Address
2724 S. Peck Rd. Monrovia CA US 91016 91016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ECI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.1998-04-20
K980053GLENROE CHAINGlenroe Technologies1998-02-24
K973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroe1997-12-01
K943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.1995-05-24
K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.1995-05-23
K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.1995-05-23
K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, Inc.1995-05-23
K932298PRO'S NEO-LASTICSProfessional Positioners, Inc.1994-02-14
K935144DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICSDentauraum, Inc.1994-02-04
K932319ORTHODONTIC ELASTOMERGac Intl., Inc.1993-09-20
K931462GLENROE CHAINGlenroe Technologies, Inc.1993-07-22
K923999ALASTIK NSUnitek Corp.1993-06-24
K930453SINGLESNexadental1993-05-27
K924140TUFF TIESGlenroe Technologies1993-04-27
K924139GLENROE ORTHO SEPSGlenroe Technologies1993-04-08