FDA.report

Henry Schein

Primary DI
10304040103415
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701215
Catalog number
5701215
Device description
Maxima Reamer 21 mm #20
Published
2019-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040103415PrimaryGS10
00304040103418Unit of UseGS10

GMDN Terms

TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.

Sterilization Methods

Method
Radiation Sterilization

Regulatory Flags

DUNS number
012430880
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D6620708732570PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732650PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732730PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733800PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733980PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708734060PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708736610PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738770PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738850PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739430PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739500PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708740810PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763180PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763260PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763340PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763420PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763750PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
05060940375786Lentulo, 25, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375793Lentulo, 30, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375809Lentulo, 35, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375816Lentulo, 40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375823Lentulo, 25-40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940379333Lentulo 25-40, 21ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375410Gates Gliddens, 1, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375427Gates Gliddens, 2, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375434Gates Gliddens, 3, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375441Gates Gliddens, 4, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375458Gates Gliddens, 5, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375465Gates Gliddens, 6, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375472Gates Gliddens, 1-6, 28ENDOPERFECTION LIMITEDEKP2023-12-11