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510(k) K801463

Device
OJ-1 ENDODONIC ROOT CANAL FILE HOLDER
Applicant
ALMORE INTL., INC.
510(k) number
K801463
Product code
EKQ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-07-21
Date received
1980-06-24
Regulation
872.4565
Classification name
Preparer, Root Canal Endodontic
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 EKQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832378VIBRATORY ENDODONTIC SYSTEMSyntex Dental Products, Inc.1983-10-04

Legacy Summary#

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FDA Review#

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