FDA.reportPublic FDA data

SIC invent Dental Implant Systems

Primary DI
04260516876766
Brand
SIC invent Dental Implant Systems
Company
SIC invent AG
Model
937248
Device description
SIC Bone Profiler Guide Pin for SICvantage, red
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04260516876766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260516876766042605168767664260516876766

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable 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