FDA.reportPublic FDA data

Implantswiss

Primary DI
07640168181987
Brand
Implantswiss
Company
Novodent SA
Model
S-TCA30
Catalog number
S-TCA30
Device description
"Tissue level Couple Abutment 5.2 x 3 mm ""Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure."""
Published
2021-03-31
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
K181266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181266000Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA2018-11-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640168181987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168181987076401681819877640168181987

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: Keep away from light and sun

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480055352
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630188201857ImplantswissS-TWSBS-TWSB2021-03-31
07630188201864ImplantswissS-TSBS-TSB2021-03-31
07630188201871ImplantswissS-PSBS-PSB2021-03-31
07630188201888ImplantswissS-PMSBS-PMSB2021-03-31
07630188201895ImplantswissS-PMUSBS-PMUSB2021-03-31
07630188201901ImplantswissS-POSBS-POSB2021-03-31
07630188203028ImplantswissS-TWFDLAS-TWFDLA2021-03-31
07630188200461ImplantswissS-T-RATCHETS-T-RATCHET2021-04-30
07630188206739ImplantswissS-BMUA48251S-BMUA482512021-08-12
07630188206746ImpantswissS-BMUA48252S-BMUA482522021-08-12
07630188206753ImplantswissS-BMUA48253S-BMUA482532021-08-12
07630188206869ImplantswissS-BIPGPs-BIPGP2021-08-12
07630188206876ImplantswissS-BMUAICPGPinS-BMUAICPGPin2021-08-12
07630188206883implantswissS-DP3.7S-DP3.72021-08-12
07630188206890ImplantswissS-DP4.3S-DP4.32021-08-12
07640168190057ImplantswissS-BMUA48251S-BMUA482512021-04-30
07640168190064ImpantswissS-BMUA48252S-BMUA482522021-04-30
07640168190071ImplantswissS-BMUAICPGPinS-BMUAICPGPin2021-04-30
07640168190088ImplantswissS-BIPGPs-BIPGP2021-04-30
07640168190095ImplantswissS-DP4.3S-DP4.32021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494138plant Implant System8dent Inc.NHA2026-10-15
088000968498028plant Implant System8dent Inc.NHA2026-10-15
088000968501748plant Implant System8dent Inc.NHA2026-10-15
088000968515228plant Implant System8dent Inc.NHA2026-10-15
088000968515398plant Implant System8dent Inc.NHA2026-10-15
088000968515538plant Implant System8dent Inc.NHA2026-10-15
088000968516078plant Implant System8dent Inc.NHA2026-10-15
088000968516148plant Implant System8dent Inc.NHA2026-10-15
088000968516218plant Implant System8dent Inc.NHA2026-10-15
088000968516388plant Implant System8dent Inc.NHA2026-10-15
088000968588358plant Implant System8dent Inc.NHA2026-10-15
088000968600678plant Implant System8dent Inc.NHA2026-10-15
088000968603028plant Implant System8dent Inc.NHA2026-10-15
088000968609068plant Implant System8dent Inc.NHA2026-10-15
088000968616758plant Implant System8dent Inc.NHA2026-10-15
088000968620618plant Implant System8dent Inc.NHA2026-10-15
088000968621848plant Implant System8dent Inc.NHA2026-10-15
088000968623378plant Implant System8dent Inc.NHA2026-10-15
088000968688728plant Implant System8dent Inc.NHA2026-10-15
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14