FDA.reportPublic FDA data

Zygomatic Implant Drill

Primary DI
07290119310524
Brand
Zygomatic Implant Drill
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
4mm Diameter x 75mm Length
Catalog number
BIO-ZDR3S
Published
2025-03-18
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
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
07290119310524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290119310524072901193105247290119310524

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

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
07290119310531Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310548Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18