FDA.reportPublic FDA data

Milling Abutment for CAD/CAM

Primary DI
07640156477429
Brand
Milling Abutment for CAD/CAM
Company
Thommen Medical AG
Model
1.04.400
Published
2016-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K151984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151984000Thommen Milling Abutment for CAD/CAMThommen Medical AG2016-03-10NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640156477429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640156477429076401564774297640156477429

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

Regulatory Flags#

DUNS number
481614829
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640182644611SPI Implant X-ray templateFo_20d3052025-09-16
07640182643355SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 8.0 mm4.23.0122024-02-14
07640182643362SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 9.5 mm4.23.0132024-02-14
07640182643379SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 11.0 mm4.23.0142024-02-14
07640182643386SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 12.5 mm4.23.0152024-02-14
07640182643393SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 14.0 mm4.23.0162024-02-14
07640182643409SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm4.23.0212024-02-14
07640182643416SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm4.23.0222024-02-14
07640182643423SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm4.23.0232024-02-14
07640182643430SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 11.0 mm4.23.0242024-02-14
07640182643447SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 12.5 mm4.23.0252024-02-14
07640182643454SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 14.0 mm4.23.0262024-02-14
07640182643461SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 6.5 mm4.23.0312024-02-14
07640182643478SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 8.0 mm4.23.0322024-02-14
07640182643485SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 9.5 mm4.23.0332024-02-14
07640182643492SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 11.0 mm4.23.0342024-02-14
07640182643508SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 12.5 mm4.23.0352024-02-14
07640182643515SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 14.0 mm4.23.0362024-02-14
07640182643522SPI®NEVO RC INICELL®, healing cap incl., PF 5.0, endosseous Ø 5.0 mm, L 6.5 mm4.23.0412024-02-14
07640182643539SPI®NEVO RC INICELL®, healing cap incl., PF 5.0, endosseous Ø 5.0 mm, L 8.0 mm4.23.0422024-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
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07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
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07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18