OPTIMUM

Primary DI
00366975011367
Brand
OPTIMUM
Company
BENCO DENTAL SUPPLY CO.
Model
4448-519
Device description
#15-40 Assorted Optimum™ Hedstroms File 31mm Pack of 6
Published
2018-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975011367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975011367003669750113673669750113670366975011367

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
570-602-6924jsoroka@benco.com

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13
D74419672861Gibson Healthcare1967-2861967-2862017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049901858rootEX instrument short 0,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049902053K-Files 21mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049950856rootEX instrument short 1,3 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049950870rootEX instrument short 1,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049950917rootEX instrument long 0,8 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049950931rootEX instrument long 1,3 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049950955rootEX instrument long 1,8 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049952584rootEX drill short shank 0,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049952591rootEX drill short shank 1,1 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049986831K-Files 29mm 008, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986848K-Files 29mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986862K-Files 29mm 015, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986886K-Files 29mm 020, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986909K-Files 29mm 025, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986923K-Files 29mm 030, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986947K-Files 29mm 035, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986961K-Files 29mm 040, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986985K-Files 29mm 045, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987005K-Files 29mm 050, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987029K-Files 29mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987043K-Files 29mm 060, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987067K-Files 29mm 070, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987081K-Files 29mm 080, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987203Hedstroem files 21mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987357Hedstroem files 25mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987401Hedstroem files 29mm 008, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987418Hedstroem files 29mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987432Hedstroem files 29mm 015, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987456Hedstroem files 29mm 020, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987470Hedstroem files 29mm 025, pu: 6 pcsDiaswiss SAEKS2023-10-02