FDA.reportPublic FDA data

SIC® Dental Implant Systems

Primary DI
04260516870085
Brand
SIC® Dental Implant Systems
Company
SIC invent AG
Model
935023
Device description
SIC Gingiva Shaper Ø 3.3 mm, cylindrical, GH 2.0 mm
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESIC9350231PreviousHIBCC0
04260516870085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260516870085042605168700854260516870085

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
+41612602460contact.usa@sic-invent.com

Regulatory Flags#

DUNS number
482083990
Device count
1
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
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08