FDA.reportPublic FDA data

MK Drill Bit

Primary DI
08800197900327
Brand
MK Drill Bit
Company
MK Meditech Inc.
Model
MKDB-DG-08 * 10EA
Device description
The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance.The MK Drill Bit is made of stainless steel (ASTM F899 420B).
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800197900327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800197900327088001979003278800197900327

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695009476
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
08800197900020ATOZ Mini-ScrewMKS-1611 and MKS-16132022-01-22
08800197900624ATOZ Mini-ScrewMKS-1610 *10EA2025-11-03
08800197901034ATOZ Mini-ScrewMKS-1608 *10EA2025-11-03
08800197901621ATOZ KeyMK Key-T-S2025-11-03
08800197900396ATOZ Utility WireMK Wire arm-1260 * 4EA2024-12-27
08800197900389Guide ATOZMK-G-082024-12-26
08800197900549Model ATOZModel ATOZ-A-UNI-F082024-12-26
08800197900556ATOZ ScrewdriverMKD-S2024-12-23
08800197900563ATOZ ScrewdriverMKD-L2024-12-23
08800197900693ATOZ KeyMK Key-S2024-12-23
08800197900631ATOZ Mini-ScrewMKS-1610 *6EA2024-12-18
08800197900648ATOZ Mini-ScrewMKS-1611 *10EA2024-12-18
08800197900655ATOZ Mini-ScrewMKS-1611 *4EA2024-12-18
08800197900662ATOZ Mini-ScrewMKS-1613 *10EA2024-12-18
08800197900679ATOZ Mini-ScrewMKS-1613 *6EA2024-12-18
08800197900686ATOZ Mini-ScrewMKS-1615 *6EA2024-12-18
08800197900372ATOZ ExpanderA-UNI-F082024-05-16
08800197900198ATOZ Mini-ScrewMKS-16112024-01-12
08800197900358ATOZ ExpanderT-UNI-F122024-01-12
08800197900334ATOZ Mini-ScrewMKS-1611 * 8EA2023-10-13

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