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510(k) K935638

Device
NITINOL, NITI
Applicant
HIGHLAND METALS
510(k) number
K935638
Product code
DZC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-18
Date received
1993-11-23
Regulation
872.5410
Classification name
Wire, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KENNETH HIGHLAND
Address
1801 Almaden Rd. Unit C San Jose CA US 95125 95125

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DZC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112640HYPERELASTIC WIREOrmco Corp.2011-11-16
K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. Geller1994-10-05
K935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.1994-02-04
K935142DENTAURUM WIRESDentauraum, Inc.1994-01-31
K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedics1994-01-21
K933374NITI COIL SPRINGSHighland Metals1993-11-19
K933377STAINLESS STEEL ARCHES REPACKER RELABETERHighland Metals1993-11-16
K933376NITI ARCH WIRE ON A SPOOLHighland Metals1993-11-12
K933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETERHighland Metals1993-11-12
K933379STAINLESS STEEL ARCHESHighland Metals1993-11-12
K933380REVERSE SURVE NITI ARCH WIREHighland Metals1993-11-12
K931631COATED ORTHODONTIC DEVICESWonder Wire1993-07-28
K930202TITAN SEPARATING SPRINGOrtho Spectrum, Inc.1993-05-27
K923837DIMPLED MULTI MODULUS ARCH WIREUltimate Wireforms, Inc.1993-03-31
K924805ORTHODONTIC ARCH WIREUltimate Wireforms, Inc.1993-03-31

Legacy Summary#

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FDA Review#

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