FDA.report

SIC invent Dental Implant Systems

Primary DI
04260516876735
Brand
SIC invent Dental Implant Systems
Company
SIC invent AG
Model
937245
Device description
SIC Bone Profiler Guide Pin for SIChex
Published
2024-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260516876735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260516876735042605168767354260516876735

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+416126042460contact.usa@sic-invent.com

Regulatory Flags

DUNS number
482083990
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04260516871006SIC invent Dental Implant Systems9352312025-02-17
04260516871013SIC invent Dental Implant Systems9352322025-02-17
04260516871020SIC invent Dental Implant Systems9352332025-02-17
04260516871037SIC invent Dental Implant Systems9352342025-02-17
04260516871075SIC invent Dental Implant Systems9352452025-02-17
04260516871082SIC invent Dental Implant Systems9352462025-02-17
04260516871099SIC invent Dental Implant Systems9352472025-02-17
04260516871105SIC invent Dental Implant Systems9352482025-02-17
04260516871112SIC invent Dental Implant Systems9352492025-02-17
04260516871129SIC invent Dental Implant Systems9352502025-02-17
04260516871136SIC invent Dental Implant Systems9352512025-02-17
04260516871143SIC invent Dental Implant Systems9352522025-02-17
04260516871150SIC invent Dental Implant Systems9352532025-02-17
04260516871167SIC invent Dental Implant Systems9352542025-02-17
04260516871174SIC invent Dental Implant Systems9352552025-02-17
04260516871181SIC invent Dental Implant Systems9352562025-02-17
04260516870191SIC invent Dental Implant Systems9350702024-12-27
04260516870207SIC invent Dental Implant Systems9350712024-12-27
04260516870214SIC invent Dental Implant Systems9350722024-12-27
04260516870221SIC invent Dental Implant Systems9350732024-12-27

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Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
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08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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