FDA.reportPublic FDA data

HexaPLUS S OneDrill Implant System

Primary DI
00810044843217
Brand
HexaPLUS S OneDrill Implant System
Company
OSSEOFUSE INTERNATIONAL, INC.
Model
OFDE
Published
2025-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044843217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044843217008100448432178100448432170810044843217

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
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
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
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03