FDA.reportPublic FDA data

Direct Screw Final Reamer

Primary DI
08800076473553
Brand
Direct Screw Final Reamer
Company
Truabutment Korea Co.,Ltd
Model
AT-DWFRM
Published
2025-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076473553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076473553088000764735538800076473553

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076417960Removal DriverRDR20S2026-03-19
08800076422872Tapered DrillTGTD35142025-12-23
08800076422889Tapered DrillTGTD42062025-12-23
08800076422902Tapered DrillTGTD42102025-12-23
08800076422919Tapered DrillTGTD42122025-12-23
08800076422926Tapered DrillTGTD42142025-12-23
08800076422735Tapered DrillTGTD22062025-12-16
08800076422742Tapered DrillTGTD22082025-12-16
08800076422759Tapered DrillTGTD22102025-12-16
08800076422766Tapered DrillTGTD22122025-12-16
08800076422773Tapered DrillTGTD22142025-12-16
08800076422780Tapered DrillTGTD28062025-12-16
08800076422797Tapered DrillTGTD28082025-12-16
08800076422803Tapered DrillTGTD28102025-12-16
08800076422810Tapered DrillTGTD28122025-12-16
08800076422827Tapered DrillTGTD28142025-12-16
08800076422834Tapered DrillTGTD35062025-12-16
08800076422841Tapered DrillTGTD35082025-12-16
08800076422858Tapered DrillTGTD35102025-12-16
08800076422865Tapered DrillTGTD35122025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EJOT1410JOTAJota AGEJL2026-07-10
D661R100699C1AlpenCOLTENE/WHALEDENT INCEJL2026-06-05
D8120513291BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
D8120513301BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC463140185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07