FDA.reportPublic FDA data

SNUCONE BONE LEVEL IMPLANT SYSTEM

Primary DI
08800020811974
Brand
SNUCONE BONE LEVEL IMPLANT SYSTEM
Company
SNUCONE Co.,LTD.
Model
ATTAHM-4510
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210354000SNUCONE Bone Level Implant SystemSnucone Co., Ltd.2022-07-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020811974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020811974088000208119748800020811974

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
9999999999snucone@naver.com

Regulatory Flags#

DUNS number
688806132
Device count
1
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
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
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07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18