FDA.reportPublic FDA data

"Contours™ Finishing & Polishing Discs Refill Pack 3/8"" Superfine"

Primary DI
00359883006259
Brand
"Contours™ Finishing & Polishing Discs Refill Pack 3/8"" Superfine"
Company
DEN-MAT HOLDINGS, LLC
Model
133011
Catalog number
133011
Device description
Aluminum oxide dental finishing and polishing abrasive discs
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00359883006259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00359883006259003598830062593598830062590359883006259

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.375Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store discs and mandrels in a dry place. Store discs away from direct sunlight.
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
Premarket exempt
true
Lot or batch
true

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D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
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D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

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