FDA.reportPublic FDA data

Implantswiss

Primary DI
07640168181727
Brand
Implantswiss
Company
Novodent SA
Model
S-BMAS
Catalog number
S-BMAS
Device description
Bone level Mini Abutment Screw 2.1 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
07640168181727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168181727076401681817277640168181727

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04