FDA.reportPublic FDA data

Slim Hex Driver 2.1mm

Primary DI
07290119310678
Brand
Slim Hex Driver 2.1mm
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
8mm Diameter x 18mm Length
Catalog number
BIO-X2810
Published
2025-03-21
Public version status
Update
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
07290119310678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290119310678072901193106787290119310678

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532209134
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290119312917Cylindrical Dental Implant CDI3.3mm diameter x 10mm lengthBIO-G33102026-05-18
07290119312924Cylindrical Dental Implant CDI3.3mm diameter x 11.5mm lengthBIO-G33112026-05-18
07290119312931Cylindrical Dental Implant CDI3.3mm diameter x 13mm lengthBIO-G33132026-05-18
07290119312948Cylindrical Dental Implant CDI3.3mm diameter x 16mm lengthBIO-G33162026-05-18
07290119312955Cylindrical Dental Implant CDI3.75mm diameter x 8mm lengthBIO-G37082026-05-18
07290119312962Cylindrical Dental Implant CDI3.75mm diameter x 10mm lengthBIO-G37102026-05-18
07290119312979Cylindrical Dental Implant CDI3.75mm diameter x 11.5mm lengthBIO-G37112026-05-18
07290119312986Cylindrical Dental Implant CDI3.75mm diameter x 13mm lengthBIO-G37132026-05-18
07290119312993Cylindrical Dental Implant CDI3.75mm diameter x 16mm lengthBIO-G37162026-05-18
07290119313006Cylindrical Dental Implant CDI4.2mm diameter x 8mm lengthBIO-G42082026-05-18
07290119313013Cylindrical Dental Implant CDI4.2mm diameter x 10mm lengthBIO-G42102026-05-18
07290119313020Cylindrical Dental Implant CDI4.2mm diameter x 11.5mm lengthBIO-G42112026-05-18
07290119313037Cylindrical Dental Implant CDI4.2mm diameter x 13mm lengthBIO-G42132026-05-18
07290119313044Cylindrical Dental Implant CDI4.2mm diameter x 16mm lengthBIO-G42162026-05-18
07290119313051Cylindrical Dental Implant CDI5mm diameter x 8mm lengthBIO-G50082026-05-18
07290119313068Cylindrical Dental Implant CDI5mm diameter x 10mm lengthBIO-G50102026-05-18
07290119313075Cylindrical Dental Implant CDI5mm diameter x 11.5mm lengthBIO-G50112026-05-18
07290119313082Cylindrical Dental Implant CDI5mm diameter x 13mm lengthBIO-G50132026-05-18
07290119313099Cylindrical Dental Implant CDI5mm diameter x 16mm lengthBIO-G50162026-05-18
07290119313105Cylindrical Dental Implant CDI6mm diameter x 8mm lengthBIO-G60082026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08