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510(k) K823686

Device
REAMER TYPE K ENDODONTIC
Applicant
UNITED DENTAL MFG., INC.
510(k) number
K823686
Product code
EKP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-28
Date received
1982-12-07
Regulation
872.4565
Classification name
Reamer, Pulp 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 EKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822620ROOT CANAL REAMERS, TYPE KUnion Broach, Div. Moyco Industries, Inc.1982-09-28
K800291ENDEX REAMERS PULP CANAL, ENDODONTICIpco Corp.1980-02-19
K770331DIALYSIS, JET SYSTEMJanneck Ent. of Texas1977-04-20
K770598ENDODONTIC INSTRUMENTS, R&R CUTWELLRansom and Randolph1977-04-05
K770367ROOT CANAL FILES & REAMERSCemco Tool Co., Inc.1977-03-01

Legacy Summary#

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FDA Review#

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