FDA.reportPublic FDA data

OneDrill Surgical Drill

Primary DI
00810044842388
Brand
OneDrill Surgical Drill
Company
OSSEOFUSE INTERNATIONAL, INC.
Model
OneDrill4513
Published
2025-11-24
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

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044842388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044842388008100448423888100448423880810044842388

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
080694564
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044841459Round Bur one size lengthOFRB-202025-11-25
00810044841466HexaPLUS S OneDrill Implant SystemHSF45082025-11-25
00810044842623HexaPLUS Dental ImplantHLCC2025-11-25
00810044842630HexaPLUS Dental ImplantHLIC2025-11-25
00810044842678HexaPLUS Dental ImplantHLAR2025-11-25
00810044842685HexaPLUS Dental ImplantHLIA2025-11-25
00810044842692HexaPLUS Dental ImplantHLCT2025-11-25
00810044842708HexaPLUS Dental ImplantHLOT2025-11-25
00810044842715HexaPLUS Dental ImplantHLBA2025-11-25
00810044842722HexaPLUS Sinus Dental ImplantRSD37852025-11-25
00810044842739HexaPLUS Sinus Dental ImplantRSD37102025-11-25
00810044842746HexaPLUS Sinus Dental ImplantOFHDR-S2025-11-25
00810044842753HexaPLUS Sinus Dental ImplantOFHDR-L2025-11-25
00810044842760OnePLUS Dental ImplantOPIA-3002025-11-25
00810044842777OnePLUS Dental ImplantOPIA-3752025-11-25
00810044842784OnePLUS Dental ImplantOPIA-4502025-11-25
00810044842791OnePLUS Dental ImplantOPIA-5252025-11-25
00810044842807OnePLUS Dental ImplantOPIC-3002025-11-25
00810044842814OnePLUS Dental ImplantOPIC-3752025-11-25
00810044842821OnePLUS Dental ImplantOPIC-4502025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E322033800150MECTRONMECTRON SPADZI2026-02-18
E322033800160MECTRONMECTRON SPADZI2026-02-18
E322034000110MECTRONMECTRON SPADZI2026-02-18
E322034000120MECTRONMECTRON SPADZI2026-02-18
E322034000130MECTRONMECTRON SPADZI2026-02-18
E322048000111010MECTRONMECTRON SPADZI2026-02-18
E322048000121010MECTRONMECTRON SPADZI2026-02-18
00810044841459Round Bur one size lengthOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842722HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842739HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842845OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842852OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842869OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843125HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843132HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843149HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843156HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843163HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843170HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843187HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843194HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843200HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843224HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842142OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842159OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842166OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842173OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842180OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842197OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842203OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24