FDA.report

Implantswiss

Primary DI
07640168187873
Company
Novodent SA
Model
S-SD2214
Catalog number
S-SD2214
Device description
Straight Drill 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
2021-03-31
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

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
07640168187873PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
07640168187873PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NDPAccessories, Implant, Dental, Endosseous1Dental872.3980NEligible

Premarket Submissions

SubmissionSupplement
K181266000

Premarket Details

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

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

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
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

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