FDA.report

DIOnavi. Straight Drill

Primary DI
08800049207697
Brand
DIOnavi. Straight Drill
Company
DIO Corporation
Model
USD 2708DN
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
08800049207697PrimaryGS10

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
631085206
Device count
1
DM exempt
true
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
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
08800049233948Extension Cemented AbutmentAEI 48007N[H]2025-09-15
08800049234006Extension Cemented AbutmentAEI 48017[H]2025-09-15
08800049234020Extension Cemented AbutmentAEI 48017N[H]2025-09-15

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