FDA.report

SIC invent Dental Implant Systems

Primary DI
04260516875615
Brand
SIC invent Dental Implant Systems
Company
SIC invent AG
Model
951623
Device description
SICvantage Extractor, extra short for prosthetics in blue or red
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

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260516875615PrimaryGS10

GMDN Terms

TermDefinition
Dental implant extractorA manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use 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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