FDA.reportPublic FDA data

WaveOne Rotary File

Primary DI
D716WOLARGE210
Brand
WaveOne Rotary File
Company
TULSA DENTAL PRODUCTS LLC
Model
WOLARGE21
Catalog number
WOLARGE21
Device description
WaveOne Recip File Large 21mm
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716WOLARGE211PrimaryHIBCC0
D716WOLARGE210Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942778564
Device count
3
DM exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D716GTPOSTFSAM1GT Post and DrillsGTPOSTFSAMGTPOSTFSAM2022-09-01
D716BP156L1BioPureBPSYRNDL2BP156L2022-10-13
D716BP156P1BioPureBPSYRNDL2BP156P2022-10-13
D716BP156SYS1BioPureBPSYRNDL2BP156SYS2022-10-13
D716BP288P1BioPureBPSYRNDL2BP288P2022-10-13
D716BP36L1BioPureBPSYRNDL2BP36L2022-10-13
D716BP36P1BioPureBPSYRNDL2BP36P2022-10-13
D716BP36SYS1BioPureBPSYRNDL2BP36SYS2022-10-13
D716BP48L1BioPureBPSYRNDL2BP48L2022-10-13
D716BP48P1BioPureBPSYRNDL2BP48P2022-10-13
D716BP48R1BioPureBPSYRNDL2BP48R2022-10-13
D716BPSYRNDL21BioPureBPSYRNDL2BPSYRNDL22022-10-13
D716PIEZOFLOWREFILL1ProUltra PiezoFlowPIEZOFLOWREFILLPIEZOFLOWREFILL2022-10-18
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065043NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065050NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065067NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065074NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065081NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065098NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065104NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065111NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
08056099233449VIVID POST DRILLBIOLOREN SRLDZA2024-03-21
07630049952607rootEX drill short shank 1,3 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952614rootEX drill short shank 1,6 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952621rootEX drill short shank 1,8 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952683rootEX drill 0,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952690rootEX drill 1,1 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952706rootEX drill 1,3 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952713rootEX drill 1,6 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952720rootEX drill 1,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952782rootEX plug short 1,0 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952799rootEX plug short 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952805rootEX plug short 1,5 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952812rootEX plug short 1,8 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952829rootEX plug short 2,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952836rootEX plug 1,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952843rootEX plug 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02