FDA.report

CleanCut™ Extended Use Diamond FG 856-021C|

Primary DI
07540172017763
Brand
CleanCut™ Extended Use Diamond FG 856-021C|
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
1273217
Catalog number
1273217
Device description
Dental Bur, Diamond, Single-use
Published
2021-07-14
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
true

Related Records

Contact Domains

Product Codes

CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172017763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172017763075401720177637540172017763

GMDN Terms

TermDefinition
Diamond dental bur, single-useA 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 single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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