FDA.reportPublic FDA data

DIOnavi. Guide Drill

Primary DI
08806169098443
Brand
DIOnavi. Guide Drill
Company
DIO Corporation
Model
UGD 2005RM
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08806169098443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806169098443088061690984438806169098443

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631085206
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800049245330Healing CapHCI 48504[H]2025-09-19
08800049245361Healing CapHCI 65704[H]2025-09-19
08800049245422Cemented CylinderICC 48508[H]2025-09-19
08800049245460Cemented CylinderICC 48588[H]2025-09-19
08800049245507Cemented CylinderICC 60649[H]2025-09-19
08800049245545Cemented CylinderICC 65309[H]2025-09-19
08800049416884Temporary CylinderITC 480102025-09-19
08806169097729Healing CapHCI 60704[H]2025-09-19
08800049414217DIOnavi GuideGUIDE 02 A01(a,b)2025-09-18
08800049414231DIOnavi GuideGUIDE 02 A02(a,b)2025-09-18
08800049414255DIOnavi GuideGUIDE 02 A03(a,b)2025-09-18
08800049414279DIOnavi GuideGUIDE 02 A04(a,b)2025-09-18
08800049414293DIOnavi GuideGUIDE 02 A05(a,b)2025-09-18
08800049438961UF(II) Eastab CylinderESMC 4812N2025-09-18
08800049438985UF(II) Eastab CylinderESMC 4812H2025-09-18
08800049438992UF(II) Eastab Cylinder Semi FinalESMCSF 4806N2025-09-18
08800049443040UF(II) Eastab Cylinder Semi FinalESMCSF 4806H2025-09-18
08800049282892Pre-milled BarCBMC 02H2025-09-16
08800049282908Pre-milled BarCBMC 02N2025-09-16
08800049283448Pre-milled BarCBZN 012025-09-16

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