FDA.reportPublic FDA data

HexaPLUS Sinus Dental Implant

Primary DI
00810044842753
Brand
HexaPLUS Sinus Dental Implant
Company
OSSEOFUSE INTERNATIONAL, INC.
Model
OFHDR-L
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
00810044842753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044842753008100448427538100448427530810044842753

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
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
00810044842838OnePLUS Dental ImplantOPIC-5252025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810646Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810653Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810684Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810691Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810707Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810714Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810721Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810738Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810745Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810752Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810769Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18