FDA.report

Impantswiss

Primary DI
07630188206746
Brand
Impantswiss
Company
Novodent SA
Model
S-BMUA48252
Catalog number
S-BMUA48252
Device description
Bone level Multi Unit Abutment 4.8 x 25 x 2 mm
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions

SubmissionSupplement
K200867000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K200867000Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA2020-04-28DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630188206746PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480055352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07630188206739ImplantswissS-BMUA48251S-BMUA482512021-08-12
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
07640168184490ImplantswissS-MUAHCapS-MUAHCap2021-05-23
07630188201338ImplantswissS-IBS-IB2021-04-30
07630188201345ImplantswissS-IBPS-IBP2021-04-30
07630188201352ImplantswissS-IBHS-IBH2021-04-30
07630188201369ImplantswissS-IBClip-yS-IBClip-y2021-04-30
07630188201444ImplantswissS-TFIC S-TFIC 2021-04-30
07630188201451ImplantswissS-OIAS-OIA2021-04-30
07630188201468ImplantswissS-BMIAS-BMIA2021-04-30
07630188200300ImplantswissS-OADLS-OADL2021-04-30
07630188200317ImplantswissS-OADSS-OADS2021-04-30
07630188200461ImplantswissS-T-RATCHETS-T-RATCHET2021-04-30
07630188200478ImplantswissS-12HDRSS-12HDRS2021-04-30
07630188200485ImplantswissS-12HDRLS-12HDRL2021-04-30
07630188201024implantswissS-BMUALAS-BMUALA2021-04-30

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07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482524IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486720NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487482RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487628IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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