FDA.reportPublic FDA data

Implantswiss

Primary DI
07640168189181
Brand
Implantswiss
Company
Novodent SA
Model
S-BCA45407
Catalog number
S-BCA45407
Device description
"Bone level Couple Abutment H7 4.5 x 4.0 x H7mm ""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
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
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
07640168189181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168189181076401681891817640168189181

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, Specify00Keep 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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