FDA.reportPublic FDA data

Countersink Drill

Primary DI
07290119310005
Brand
Countersink Drill
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
4.2mm diameter x 28.3mm length
Catalog number
BIO-D1034
Published
2025-03-11
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
QRQNon-Irrigation Endosseous Dental Implant Drill Bits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRQNon-Irrigation Endosseous Dental Implant Drill BitsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290119310005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290119310005072901193100057290119310005

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
00810157313881Starter DrillParagon Implant Mfg., LLCQRQ2026-01-07
00810157313898Step Drill 2.3/2.0Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313904Step Drill 2.8/2.3Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313911Step Drill 3.4/2.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313928Step Drill 3.8/3.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313935Step Drill 4.4/3.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313942Step Drill 4.8/4.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313959Step Drill 5.1/4.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313966Step Drill 5.4/5.1Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313027Lindemann DrillParagon Implant Mfg., LLCQRQ2025-12-30
00810157312952Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312969Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312938Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312945Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312631Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-18
00810157310101Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312594Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312600Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312617Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312624Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
07290119310449Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310456Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310463Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310470Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310487Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310494Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310500Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310517Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310524Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310531Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18