FDA.reportPublic FDA data

GUIDE PIN

Primary DI
08800020849113
Brand
GUIDE PIN
Company
SNUCONE Co.,LTD.
Model
GPIN-M
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

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
08800020849113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020849113088000208491138800020849113

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference pinA non-sterile device in the form of a metal rod designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling of holes in the jawbone for implant placement/fixation). It is a cylindrical metal pin placed in the holes of the reference plate to form a link between the chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999snucone@naver.com

Regulatory Flags#

DUNS number
688806132
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020807151SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4810-72026-09-22
08800020807168SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4820-72026-09-22
08800020807175SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4830-72026-09-22
08800020807182SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4840-72026-09-22
08800020807199SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-52026-09-22
08800020807205SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-52026-09-22
08800020807212SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-52026-09-22
08800020807229SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-52026-09-22
08800020807236SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-72026-09-22
08800020807243SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-72026-09-22
08800020807250SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-72026-09-22
08800020807267SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-72026-09-22
08800020807311SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4810-72026-09-22
08800020807328SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4820-72026-09-22
08800020807335SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4830-72026-09-22
08800020807342SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4840-72026-09-22
08800020807359SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6010-52026-09-22
08800020807366SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6020-52026-09-22
08800020807373SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6030-52026-09-22
08800020807380SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6040-52026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14