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510(k) K800293

Device
FILE, PULP CANAL
Applicant
IPCO CORP.
510(k) number
K800293
Product code
EKS  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-19
Date received
1980-02-11
Regulation
872.4565
Classification name
File, 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 EKS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.2006-12-13
K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.2001-03-28
K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom Dental1997-05-22
K970649HERO 642Micro-Mega1997-05-16
K962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom Dental1996-06-04
K953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.1995-09-28
K935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco Industries, Inc.1994-01-03
K932529LIGHTSPEED DENTAL HAND INSTRUMENTLightspeed Endodontics1993-11-04
K933582PROFILE SERIES 29 FILESTulsa Dental Products, Ltd.1993-10-20
K902018DENTAURUM CERAMIC DEBONDING UNITDentauraum, Inc.1991-04-03
K905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESAngiosystems, Inc.1991-03-05
K905640SOLID CORE GUTTA PERCHA CARRIERThe Hygenic Corp.1991-03-05
K901037VISIONER 21-AJ. Morita USA, Inc.1990-08-14
K897195A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)A Company, Inc.1990-05-31
K883418DE-BOND 200Scheu-Dental1989-10-24

Legacy Summary#

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FDA Review#

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