FDA.reportPublic FDA data

HexaPLUS S OneDrill Implant System

Primary DI
00810044841497
Brand
HexaPLUS S OneDrill Implant System
Company
OSSEOFUSE INTERNATIONAL, INC.
Model
HSF4511
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243078000HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044841497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044841497008100448414978100448414970810044841497

GMDN Terms#

Term, Definition table
TermDefinition
Basket endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a single, double, and/or triple contiguous cylinder(s) that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080694564
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711456prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780126Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29