FDA.reportPublic FDA data

Carbide bur Diacarb FG XL

Primary DI
07630049981584
Brand
Carbide bur Diacarb FG XL
Company
Diaswiss SA
Model
316001.014
Device description
Dental carbide instrument for intraoral use
Published
2023-10-02
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

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630049981591PrimaryGS10
07630049981584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630049981591076300499815917630049981591
07630049981584076300499815847630049981584

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480296552
Device count
6
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630049901063Porcelain Veneer Set1VeneerSetPD2023-12-01
07630049901087Porcelain Veneer Set1PhucDangSet2023-12-01
07630049901100A-Z Modern Cavity Set1ModernCavitySe2023-12-01
07630049901391RootEX standard 0.8 (sample)935L.Set008-sam2023-12-01
07630049901407RootEX standard 011(sample)935L.Set011-sam2023-12-01
07630049901414RootEX standard 1.6 (sample)935L.Set016-sam2023-12-01
07630049901421RootEX standard 1.8 (sample)935L.Set018-sam2023-12-01
07630049901438RootEX standard 0.8 (sample)935K.Set008-sam2023-12-01
07630049901452RootEX standard 1.1 (sample)935K.Set011-sam2023-12-01
07630049901469RootEX standard 1.6 (sample)935K.Set016-sam2023-12-01
07630049901483RootEX standard 1.8 (sample)935K.Set018-sam2023-12-01
07630049901490Phuc Dang Set21PhucDangSet22023-12-01
07630049901520Hedstroem files 25mm 045 - 080, pu: 6325025.45802023-12-01
07630049901537Reamer 31mm 45 - 80, pu: 6 pcs231031.45802023-12-01
076300499018721Dr.XochipaSet Full Prep Set1Dr.XochipaSet2023-12-01
07630049902817Surgicut Set314Z164-set.0152023-12-01
07630049902824Porcelain Adjustment Kit RA K011AdjustmentKit2023-12-01
07630049950894rootEX instrument set short, pu: 2 pcs937K.Set2023-12-01
07630049950979rootEX instrument set long, pu: 2 pcs937L.Set2023-12-01
07630049951006Set FG diamonds short shank1ShortSet2023-12-01

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