FDA.reportPublic FDA data

Derbarzt Edentulous Scanbody

Primary DI
08800303549266
Brand
Derbarzt Edentulous Scanbody
Company
HUB Biotech Co.,Ltd.
Model
AXFSBSB
Catalog number
AXFSBSB
Device description
Flag Scan Body Short Triangle Body
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800303549266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800303549266088003035492668800303549266

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695071932
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800303549174Derbarzt Edentulous ScanbodyAXFSBLAXFSBL2026-01-28
08800303549181Derbarzt Edentulous ScanbodyAXFSBL45LAXFSBL45L2026-01-28
08800303549198Derbarzt Edentulous ScanbodyAXFSBL45LBAXFSBL45LB2026-01-28
08800303549204Derbarzt Edentulous ScanbodyAXFSBL45RAXFSBL45R2026-01-28
08800303549211Derbarzt Edentulous ScanbodyAXFSBL45RBAXFSBL45RB2026-01-28
08800303549228Derbarzt Edentulous ScanbodyAXFSBLBAXFSBLB2026-01-28
08800303549235Derbarzt Edentulous ScanbodyAXFSBMAXFSBM2026-01-28
08800303549242Derbarzt Edentulous ScanbodyAXFSBMBAXFSBMB2026-01-28
08800303549259Derbarzt Edentulous ScanbodyAXFSBSAXFSBS2026-01-28
08800303549273Derbarzt Edentulous ScanbodyAXMSBAXMSB2026-01-28
08800303549280Derbarzt Edentulous ScanbodyAXMSBBAXMSBB2026-01-28
08800303549297Derbarzt Edentulous ScanbodyFSBS_BFSBS_B2026-01-28
08800303549303Derbarzt Edentulous ScanbodyFSBS_GFSBS_G2026-01-28
08800303549310Derbarzt Edentulous ScanbodyFSBS_PFSBS_P2026-01-28
08800303549327Derbarzt Edentulous ScanbodyFSBS_YFSBS_Y2026-01-28
08800303549334Derbarzt Edentulous ScanbodyMSBBTMSBBT2026-01-28
08800303549341Derbarzt Edentulous ScanbodyMSBRLMSBRL2026-01-28
08800303549358Derbarzt Edentulous ScanbodyMSBRLWMSBRLW2026-01-28
08800303549365Derbarzt Edentulous ScanbodyMSBRMMSBRM2026-01-28
08800303549372Derbarzt Edentulous ScanbodyMSBRMWMSBRMW2026-01-28

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Primary DI, Brand, Company table
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00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
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