FDA.reportPublic FDA data

Sabur By 3D Dental

Primary DI
00810126507464
Brand
Sabur By 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
1
Catalog number
DB-847-012F
Device description
Flat End Cylinder Disposable Diamond 847-012F 10/Pk
Published
2025-12-16
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
00810126507464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126507464008101265074648101265074640810126507464

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080194935
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16
00810126508201Essentials By 3D DentalPTC-Y2026-03-12
008171690293113D DentalKF21082026-03-12
00810126508218Essentials By 3D DentalPBBT-1002026-03-11
00810126508225Essentials By 3D DentalPBBT-202026-03-11
00810126508232Basik by 3D DentalBPGC345T2026-03-11
00810126508249Basik by 3D DentalBPGC316T2026-03-11
00810126508256Basik by 3D DentalBPGC304T2026-03-11
00810126508263Basik by 3D DentalBPGC303T2026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7717248LTF1Dental CityICP, INC.EJL2026-05-26
D7717270021Dental CityICP, INC.EJL2026-05-26
D7717270031Dental CityICP, INC.EJL2026-05-26
D7717270041Dental CityICP, INC.EJL2026-05-26
D7717270061Dental CityICP, INC.EJL2026-05-26
D7717270081Dental CityICP, INC.EJL2026-05-26
D7717270091Dental CityICP, INC.EJL2026-05-26
D7717271041Dental CityICP, INC.EJL2026-05-26
D7717271061Dental CityICP, INC.EJL2026-05-26
D7717271081Dental CityICP, INC.EJL2026-05-26
D7717271141Dental CityICP, INC.EJL2026-05-26
D7717272041Dental CityICP, INC.EJL2026-05-26
D7717272051Dental CityICP, INC.EJL2026-05-26
D7717272061Dental CityICP, INC.EJL2026-05-26
D7717272141Dental CityICP, INC.EJL2026-05-26
D7717272741Dental CityICP, INC.EJL2026-05-26
D7717273031Dental CityICP, INC.EJL2026-05-26
D7717273041Dental CityICP, INC.EJL2026-05-26
D7717273771Dental CityICP, INC.EJL2026-05-26
D7717273781Dental CityICP, INC.EJL2026-05-26
D7717273791Dental CityICP, INC.EJL2026-05-26
D7717274041Dental CityICP, INC.EJL2026-05-26
D7717274061Dental CityICP, INC.EJL2026-05-26
D7717274081Dental CityICP, INC.EJL2026-05-26
D7717275721Dental CityICP, INC.EJL2026-05-26
D7717275831Dental CityICP, INC.EJL2026-05-26
D7717276131Dental CityICP, INC.EJL2026-05-26
D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26