FDA.report

Contours™ Finishing & Polishing Discs 3/8" Starter Kit

Primary DI
07540172016674
Brand
Contours™ Finishing & Polishing Discs 3/8" Starter Kit
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
133002
Catalog number
133002
Device description
Aluminum oxide dental finishing and polishing abrasive discs
Published
2019-06-12
Public version status
Update
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
EHJDISK, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172016674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172016674075401720166747540172016674

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store discs and mandrels in a dry place. Store discs away from direct sunlight.

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
true
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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