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510(k) K823323

Device
DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS
Applicant
MILTEX, INC.
510(k) number
K823323
Product code
EIY  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-24
Date received
1982-11-08
Regulation
872.4565
Classification name
Instrument, Filling, Plastic, Dental
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 EIY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871909COMPOSITE RESTORATIVE CARRIERDentsply Intl.1987-05-27
K8517261760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMENArtiberia1985-07-02
K833955NOVEL DISPENSER/PACKAGEDentsply Intl.1984-01-03
K830776MICROFIL CONTOURING INSTRUMENTSAlmore Intl., Inc.1983-04-28

Legacy Summary#

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FDA Review#

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