FDA.reportPublic FDA data

DentaSwiss

Primary DI
07640169736391
Brand
DentaSwiss
Company
Biodenta Swiss AG
Model
CAD-TSBBDBLB1S
Device description
TiOS Scan Body with Screw Compatible with Biodenta B1
Published
2023-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07640169736391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640169736391076401697363917640169736391

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
484609081
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640169730788DentaSwissGS-360PL212025-04-01
07640169732577DentaSwissGS-36ANK45 2025-04-01
07640169732805DentaSwissGS-36ANK56 2025-04-01
07640169735356DentaSwissGS-363PNNP 2025-04-01
07640169735431DentaSwissGS-363PNWP 2025-04-01
07640169735714DentaSwissGS-36GEN41 2025-04-01
07640169735721DentaSwissGS-36GEN51 2025-04-01
07640169735783DentaSwissGS-36GEN582025-04-01
07640169735837DentaSwissGS-36KPP41 2025-04-01
07640169735844DentaSwissGS-36KPP51 2025-04-01
07640169735851DentaSwissGS-36KPP582025-04-01
07640169731402BiodentaCAD-SBOTS35CAD-SBOTS352020-06-05
07640169731419BiodentaCAD-SBOTS45CAD-SBOTS452020-06-05
07640169735479BiodentaCAD-SBNBNPICAD-SBNBNPI2020-06-05
07640169735486BiodentaCAD-SBNBRPICAD-SBNBRPI2020-06-05
07640169735493BiodentaCAD-SBNBWPICAD-SBNBWPI2020-06-05
07640169735509BiodentaCAD-SBNB60ICAD-SBNB60I2020-06-05
07640169735516BiodentaCAD-SBNBANPCAD-SBNBANP2020-06-05
07640169735523BiodentaCAD-SBNBARPCAD-SBNBARP2020-06-05
07640169735530BiodentaCAD-SB3IC34CAD-SB3IC342020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
05397311032789Driver Hex 0.9 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032796Driver Hex 1.2 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032802Driver Hex 1.3 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032819Angled DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032833SCS DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032840Unigrip DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032857Multi-Unit DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032864FlexDrive® Aluminium Tray PHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032895Driver BioHorizons 4.5HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032901Driver BioHorizons 5.7HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26