FDA.report

MDT Diamond Coated Dental Discs

Primary DI
07291046715413
Brand
MDT Diamond Coated Dental Discs
Company
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
Model
356514220-D5
Catalog number
356514220
Device description
Rotary DISCS for dental application
Published
2024-05-06
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

Contact Domains

Product Codes

CodeName
EHJDISK, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07291046715413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07291046715413072910467154137291046715413

GMDN Terms

TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). 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

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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
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