FDA.reportPublic FDA data

VITA ENAMIC Polishing Set

Primary DI
E292ERWEC6F60
Brand
VITA ENAMIC Polishing Set
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
ERWEC6F6
Device description
Polishing instrument clinical, cup, VI-EC6f High-gloss polish (gray), 6 pcs.
Published
2023-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E292ERWEC6F60PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)8283839info@vitanorthamerica.com

Regulatory Flags#

DUNS number
315165357
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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J01701075740n!ce® Zirconia GT010.75742026-01-22
J01701075760n!ce® Zirconia GT010.75762026-01-22
J01701075770n!ce® Zirconia GT010.75772026-01-22
J01701075780n!ce® Zirconia GT010.75782026-01-22
J01701075790n!ce® Zirconia GT010.75792026-01-22
J01701075810n!ce® Zirconia GT010.75812026-01-22
J01701075820n!ce® Zirconia GT010.75822026-01-22
J01701075830n!ce® Zirconia GT010.75832026-01-22
J01701075840n!ce® Zirconia GT010.75842026-01-22
J01701075860n!ce® Zirconia GT010.75862026-01-22
J01701075870n!ce® Zirconia GT010.75872026-01-22
J01701075880n!ce® Zirconia GT010.75882026-01-22
J01701075890n!ce® Zirconia GT010.75892026-01-22

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Primary DI, Brand, Company table
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