FDA.reportPublic FDA data

MDT Tungsten Carbide Dental Burs

Primary DI
07291046609835
Brand
MDT Tungsten Carbide Dental Burs
Company
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
Model
50000210-F8-46
Catalog number
FG.TC2
Device description
Rotary carbide instrument for dental application
Published
2024-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07291046609835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07291046609835072910466098357291046609835

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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

Contacts#

Phone, Email table
PhoneEmail
+97246094422plahav@mdtdental.com

Regulatory Flags#

DUNS number
600226468
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
67291046608465MDT Tungsten Carbide Dental Burs -Sterile5001/206-R8-8CRA.TC1/22024-05-16
17291046001797MDT Diamond Coated Dental Burs1032L10-44-01032L-010M2024-05-12
17291046001803MDT Diamond Coated Dental Burs1032L12-43-01032L-012F2024-05-12
17291046002039MDT Diamond Coated Dental Burs103L212-43-01032L-012F2024-05-12
17291046016173MDT Diamond Coated Dental Burs1DM1.016-44-01DM1.0-016M2024-05-12
17291046016180MDT Diamond Coated Dental Burs1DM1.516-44-01DM1.5-016M2024-05-12
17291046016197MDT Diamond Coated Dental Burs1DM2.017-44-01DM2.0-017M2024-05-12
17291046016203MDT Diamond Coated Dental Burs1DM2.518-44-01DM2.5-018M2024-05-12
17291046330811MDT Diamond Coated Dental Burs100106-33-P1001-006SF2024-05-12
17291046330828MDT Diamond Coated Dental Burs100108-44-P1001-008M2024-05-12
17291046330835MDT Diamond Coated Dental Burs100109-34-P1001-009SM2024-05-12
17291046330842MDT Diamond Coated Dental Burs100109-43-P1001-009F2024-05-12
17291046330859MDT Diamond Coated Dental Burs100109-44-P1001-009M2024-05-12
17291046330866MDT Diamond Coated Dental Burs100109-45-P1001-009C2024-05-12
17291046330873MDT Diamond Coated Dental Burs100110-34-P1001-010SM2024-05-12
17291046330880MDT Diamond Coated Dental Burs100110-35-P1001-010SC2024-05-12
17291046330897MDT Diamond Coated Dental Burs100110-43-P1001-010F2024-05-12
17291046330903MDT Diamond Coated Dental Burs100110-44-P1001-010M2024-05-12
17291046330910MDT Diamond Coated Dental Burs100110-45-P1001-010C2024-05-12
17291046330927MDT Diamond Coated Dental Burs100110-46-P1001-010XC2024-05-12

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