FDA.report

IT Twist Drill Long

Primary DI
08800026112754
Brand
IT Twist Drill Long
Company
WARANTEC.Co.,Ltd
Model
D20-L
Published
2023-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800026112754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800026112754088000261127548800026112754

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688857820
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800026100829IU Fixture FIU360852023-04-12
08800026100836IU Fixture FIU361002023-04-12
08800026100843IU FixtureFIU361152023-04-12
08800026100850IU FixtureFIU361302023-04-12
08800026100867IU FixtureFIU400702023-04-12
08800026100874IU FixtureFIU400852023-04-12
08800026100881IU FixtureFIU401002023-04-12
08800026100898IU FixtureFIU401152023-04-12
08800026100904IU FixtureFIU401302023-04-12
08800026100911IU FixtureFIU450702023-04-12
08800026100928IU FixtureFIU450852023-04-12
08800026100935IU FixtureFIU451002023-04-12
08800026100942IU FixtureFIU451152023-04-12
08800026100959IU FixtureFIU451302023-04-12
08800026100966IU FixtureFIU500702023-04-12
08800026100973IU FixtureFIU500852023-04-12
08800026100980IU FixtureFIU501002023-04-12
08800026100997IU FixtureFIU501152023-04-12
08800026101000IU FixtureFIU501302023-04-12
08800026101017IU FixtureFIU550702023-04-12

Other Devices Sharing Product Codes

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