FDA.reportPublic FDA data

Biodenta

Primary DI
07640169734946
Brand
Biodenta
Company
Biodenta Swiss AG
Model
CAD-THANANPS
Catalog number
CAD-THANANPS
Device description
Ti Hybrid part with Screw compatible to Nobel Active NP GH0.75
Published
2020-06-20
Public version status
New
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150296000Biodenta Customized Abutment-HybridBiodenta Swiss AG2015-07-02NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640169734946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640169734946076401697349467640169734946

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
484609081
Device count
1
Lot or batch
true
Sterilization required before use
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
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23
088000968582178plant Implant System8dent Inc.NHA2026-10-23
088000968582248plant Implant System8dent Inc.NHA2026-10-23
088000968582318plant Implant System8dent Inc.NHA2026-10-23
088000968585528plant Implant System8dent Inc.NHA2026-10-23
088000968587058plant Implant System8dent Inc.NHA2026-10-23
088000968599008plant Implant System8dent Inc.NHA2026-10-23
088000968600298plant Implant System8dent Inc.NHA2026-10-23
088000968600508plant Implant System8dent Inc.NHA2026-10-23
088000968601808plant Implant System8dent Inc.NHA2026-10-23
088000968602038plant Implant System8dent Inc.NHA2026-10-23
088000968608768plant Implant System8dent Inc.NHA2026-10-23
088000968611948plant Implant System8dent Inc.NHA2026-10-23
088000968617368plant Implant System8dent Inc.NHA2026-10-23
088000968617438plant Implant System8dent Inc.NHA2026-10-23
088000968618288plant Implant System8dent Inc.NHA2026-10-23
088000968618358plant Implant System8dent Inc.NHA2026-10-23
088000968620098plant Implant System8dent Inc.NHA2026-10-23
088000968620168plant Implant System8dent Inc.NHA2026-10-23
088000968620238plant Implant System8dent Inc.NHA2026-10-23
088000968622698plant Implant System8dent Inc.NHA2026-10-23
088000968622768plant Implant System8dent Inc.NHA2026-10-23
088000968650248plant Implant System8dent Inc.NHA2026-10-23
088000968650798plant Implant System8dent Inc.NHA2026-10-23
088000968688418plant Implant System8dent Inc.NHA2026-10-23
088000968688588plant Implant System8dent Inc.NHA2026-10-23