Gingiva former (4-lobe), narrow, PF 3.5, H 4.5 mm

GUDID 07640182642198

Thommen Medical AG

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640182642198
NIH Device Record Key8369deb4-8936-4205-a0ba-e8652da3ec2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGingiva former (4-lobe), narrow, PF 3.5, H 4.5 mm
Version Model Number4.04.330
Company DUNS481614829
Company NameThommen Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640182642198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


[07640182642198]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-01
Device Publish Date2023-05-24

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07640182643409 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm2024-02-22
07640182643416 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm2024-02-22
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