FDA.reportPublic FDA data

Biodenta

Primary DI
07640169732102
Brand
Biodenta
Company
Biodenta Swiss AG
Model
CAD-CASNANP
Catalog number
CAD-CASNANP
Device description
Abutment Screw Compatible with Nobel Active NP
Published
2016-09-29
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151295000Biodenta Customized Abutment - TitaniumBiodenta Swiss AG2015-12-01NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640169732102PrimaryGS10
97640169732105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640169732102076401697321027640169732102
9764016973210597640169732105

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA non-sterile device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
484609081
Device count
4
Lot or batch
true
Expiration date on label
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
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
07290112854148NAUNIQA DENTAL LTDNHA2026-07-19
07290112854407NAUNIQA DENTAL LTDNHA2026-07-19
07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
07290118177357NAUNIQA DENTAL LTDNHA2026-07-19
07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092185391PreatPreat CorporationNHA2025-12-22