FDA.reportPublic FDA data

Base Reamer

Primary DI
08800076473454
Brand
Base Reamer
Company
Truabutment Korea Co.,Ltd
Model
ST46-BRMS
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800076473454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076473454088000764734548800076473454

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
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
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
08800076409989Impression Post Pick-Up Type ScrewUIPPNS152026-03-24
08800076409996Impression Post Pick-Up Type ScrewUIPPNS192026-03-24
08800076410008Impression Post Pick-Up Type ScrewUIPPNS212026-03-24
08800076410015Impression Post Pick-Up Type ScrewUIPPNS252026-03-24
08800076410022Impression Post Pick-Up Type ScrewUIPPS162026-03-24
08800076410039Impression Post Pick-Up Type ScrewUIPPS202026-03-24
08800076410046Impression Post Pick-Up Type ScrewUIPPS222026-03-24
08800076410053Impression Post Pick-Up Type ScrewUIPPS262026-03-24
08800076414440AOT Digital AnalogCMM-ATDLA2026-03-24
08800076414662Multi-Unit Burn Out CylinderUMBC50H2026-03-24
08800076414679Multi-Unit Burn Out CylinderUMBC50N2026-03-24
08800076418073Drill ExtensionDEH45142026-03-24
08800076423664URIS Scan PostUSPN40182026-03-24
08800076423671URIS Scan PostUSPN40282026-03-24
08800076423688URIS Scan PostUSPN40382026-03-24
08800076423695URIS Scan PostUSPR45082026-03-24
08800076423701URIS Scan PostUSPR45182026-03-24
08800076423718URIS Scan PostUSPR45282026-03-24
08800076423725URIS Scan PostUSPR45382026-03-24
08800076423756TruScan Post Kit CaseBHN-SBCASE2026-03-24

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