FDA.reportPublic FDA data

SIC invent Dental Implant Systems

Primary DI
04260516873161
Brand
SIC invent Dental Implant Systems
Company
SIC invent AG
Model
936211
Device description
SIC Transfer Abutment Ø 3.3 mm, Open Tray Technique, long (incl. SIC Fixation Screw 22.5 mm)
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260516873161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260516873161042605168731614260516873161

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+416126042460contact.usa@sic-invent.com

Regulatory Flags#

DUNS number
482083990
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260516873062SIC invent Dental Implant Systems9361902026-06-08
04260516873079SIC invent Dental Implant Systems9361912026-06-08
04260516873086SIC invent Dental Implant Systems9361922026-06-08
04260516873093SIC invent Dental Implant Systems9361962026-06-08
04260516873109SIC invent Dental Implant Systems9361972026-06-08
04260516873116SIC invent Dental Implant Systems9361982026-06-08
04260516873338SIC invent Dental Implant Systems9362222026-06-08
04260516873345SIC invent Dental Implant Systems9362232026-06-08
04260516873352SIC invent Dental Implant Systems9507872026-06-08
04260516873369SIC invent Dental Implant Systems9507882026-06-08
04260516873376SIC invent Dental Implant Systems9507892026-06-08
04260516873628SIC invent Dental Implant Systems9365282026-06-08
04260516874465SIC invent Dental Implant Systems9362262026-06-08
04260516874472SIC invent Dental Implant Systems9362272026-06-08
04260516874533SIC invent Dental Implant Systems9362242026-06-08
04260516874540SIC invent Dental Implant Systems9362252026-06-08
04260516874557SIC invent Dental Implant Systems9507842026-06-08
04260516874564SIC invent Dental Implant Systems9507852026-06-08
04260516874571SIC invent Dental Implant Systems9507862026-06-08
04260516874700SIC invent Dental Implant Systems9362782026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03