FDA.report

Base Reamer

Primary DI
08800076473423
Brand
Base Reamer
Company
Truabutment Korea Co.,Ltd
Model
UR-BRML
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

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800076473423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800076473423088000764734238800076473423

GMDN Terms

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
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

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08800076423725URIS Scan PostUSPR45382026-03-24
08800076423756TruScan Post Kit CaseBHN-SBCASE2026-03-24

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