FDA.reportPublic FDA data

Sendoline

Primary DI
17310230007633
Brand
Sendoline
Company
Directa AB
Model
S5 Rotary Files Sterile Intro Kit #1-5 23mm
Catalog number
44230010BS
Published
2022-12-05
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

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
17310230007633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023000763317310230007633

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
353954381
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
17310231029993ProphyCare HAp6901082025-09-01
17310230021639LuxatorLK7506331U2025-02-19
17310230021646LuxatorLK VET506332U2025-02-19
17310230021196TrollBagCamera Sleeve 306, 500 pcs132003062022-12-09
17310230021202Camera SleeveTrollBag XL, 300 pcs132003002022-12-09
17310230400304Ceramir Crown & Bridge QuikCap102572024-03-28
17310230102772Ceramir Crown & Bridge QuikMix102772024-03-28
17310230102789Ceramir Crown & Bridge QuikMix102782024-03-28
17310230400373Ceramir BIC QuikCap102912024-03-28
17310230400328Ceramir Crown & Bridge QuikMix400322024-03-28
17310230021318LuxatorLK4506330U2022-12-07
17310230021325LuxatorLK7506331U2022-12-07
17310230021332LuxatorLK VET506332U2022-12-07
17310230021424LuxatorSK4506333U2022-12-07
17310230021622LuxatorP Kit506635U2022-12-07
17310230021585LuxatorP1506631U2022-12-07
17310230021592LuxatorP2506632U2022-12-07
17310230021608LuxatorP3506633U2022-12-07
17310230021615LuxatorP4506634U2022-12-07
17310230021493LuxatorL2S TiN506434U2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415271Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792170Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792187Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792194Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792200Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792217Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792224Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792231Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792248Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792255Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792279Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20