FDA.reportPublic FDA data

Alpen Diamonds

Primary DI
07630243603053
Brand
Alpen Diamonds
Company
Dent4You AG
Model
60031815
Catalog number
60031815
Device description
Alpen Diamonds, G390 Bullet 014-03.0-EF, FG, 5pcs
Published
2023-08-24
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

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630243612840PrimaryGS10
07630243603053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630243612840076302436128407630243612840
07630243603053076302436030537630243603053

GMDN Terms

TermDefinition
Diamond dental bur, reusableA 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 reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480152811
Device count
5
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07630243600595BRILLIANT Crios60019985600199852026-02-10
07630243600601BRILLIANT Crios60019986600199862026-02-10
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07630243600625BRILLIANT Crios60019988600199882026-02-10
07630243600632BRILLIANT Crios60019989600199892026-02-10
07630243600649BRILLIANT Crios60019990600199902026-02-10
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07630243600663BRILLIANT Crios60019992600199922026-02-10
07630243600670BRILLIANT Crios60019993600199932026-02-10
07630243600687BRILLIANT Crios60019994600199942026-02-10
07630243600694BRILLIANT Crios60019995600199952026-02-10
07630243600700BRILLIANT Crios60019996600199962026-02-10
07630243600717BRILLIANT Crios60019997600199972026-02-10
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07630243600731BRILLIANT Crios60019999600199992026-02-10

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