FDA.report

DENTECH

Primary DI
04560218663177
Brand
DENTECH
Company
DENTECH CORPORATION
Model
02111012
Device description
Valucanite Burs #AK, SMALL, set of 6 pcs
Published
2020-09-24
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

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560218663177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560218663177045602186631774560218663177

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, 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 reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
700723000
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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04560218676818DENTECH300147422024-01-17
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04560218660718DENTECH500300002021-09-30
04560218660442DENTECH010182122020-09-24
04560218660589DENTECH507106002020-09-24
04560218660596DENTECH507107002020-09-24
04560218667120DENTECH061221002020-09-24
04560218667243DENTECH063010102020-09-24
04560218667489DENTECH070001002020-09-24
04560218667496DENTECH070001012020-09-24
04560218667502DENTECH070001022020-09-24
04560218667519DENTECH070001032020-09-24
04560218667533DENTECH070001052020-09-24
04560218667540DENTECH070001062020-09-24
04560218668493DENTECH070001502020-09-24
04560218669377DENTECH010182132020-09-24
04560218669452DENTECH010149022020-09-24
04560218669469DENTECH010149032020-09-24
04560218669476DENTECH010149072020-09-24
04560218669483DENTECH010149082020-09-24

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