FDA.reportPublic FDA data

TIE Scanbody

Primary DI
08800303549457
Brand
TIE Scanbody
Company
HUB Biotech Co.,Ltd.
Model
UTIESBK
Catalog number
UTIESBK
Device description
TIE Scanbody KIT Universal
Published
2026-01-06
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
08800303549457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800303549457088003035494578800303549457

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
08800303549266Derbarzt Edentulous ScanbodyAXFSBSBAXFSBSB2026-01-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14