FDA.report

MDT Diamond Coated Dental Burs

Primary DI
57291046352859
Brand
MDT Diamond Coated Dental Burs
Company
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
Model
104127-44-5I
Catalog number
041-027M
Device description
Rotary diamond instrument for dental application
Published
2024-05-12
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

Related Records

Product Codes

CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
57291046352859PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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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