FDA.report

Implantswiss

Primary DI
07630188200300
Brand
Implantswiss
Company
Novodent SA
Model
S-OADL
Catalog number
S-OADL
Device description
Octa Abutment Driver Long Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses.
Published
2021-04-30
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
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Premarket Submissions

SubmissionSupplement
K181266000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630188200300PrimaryGS10

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480055352
Device count
1
DM exempt
true
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
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
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
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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