FDA.reportPublic FDA data

BioHorizons

Primary DI
00847236028046
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
CRIDR18
Device description
Conical Regular Implant-level Driver, Ratchet, 18mm
Published
2026-04-01
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
00847236027681Direct MarkingGS10
00847236028046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236027681008472360276818472360276810847236027681
00847236028046008472360280468472360280460847236028046

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
967279910
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
00847236025762BioHorizonsCNODS12026-04-06
00847236025779BioHorizonsCNODS22026-04-06
00847236025786BioHorizonsCNODS32026-04-06
00847236025793BioHorizonsCNODS42026-04-06
00847236025809BioHorizonsCRODS12026-04-06
00847236025816BioHorizonsCRODS22026-04-06
00847236025823BioHorizonsCRODS32026-04-06
00847236025830BioHorizonsCRODS42026-04-06
00847236027971BioHorizonsCNIDH112026-04-01
00847236027988BioHorizonsCNIDH182026-04-01
00847236027995BioHorizonsCNIDR112026-04-01
00847236028008BioHorizonsCNIDR182026-04-01
00847236028015BioHorizonsCRIDH112026-04-01
00847236028022BioHorizonsCRIDH182026-04-01
00847236028039BioHorizonsCRIDR112026-04-01
00847236028053BioHorizonsPROID302026-04-01
00847236028060BioHorizonsPROID3342026-04-01
00847236028077BioHorizonsPROID382026-04-01
00847236028084BioHorizonsPROID422026-04-01
00847236028091BioHorizonsPROID462026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07