FDA.reportPublic FDA data

BioHorizons

Primary DI
00847236028039
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
CRIDR11
Device description
Conical Regular Implant-level Driver, Ratchet, 11mm
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
00847236028039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236028039008472360280398472360280390847236028039

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
DM exempt
true
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
00847236028046BioHorizonsCRIDR182026-04-01
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
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002021Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002038Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002045Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002052Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002076Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14