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510(k) K823326

Device
DENTAL INSTRUMENTS - CUTTING INSTRUMENT
Applicant
MILTEX, INC.
510(k) number
K823326
Product code
ELA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-24
Date received
1982-11-08
Regulation
872.4565
Classification name
Instrument, Hand, Calculus Removal
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 ELA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)Ela Medical, Inc.1995-08-15
K854168TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTESTravenol Laboratories, S.A.1986-03-13
K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology1980-11-12

Legacy Summary#

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FDA Review#

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