SNUCONE TISSUE LEVEL IMPLANT SYSTEM

Primary DI
08800020807311
Brand
SNUCONE TISSUE LEVEL IMPLANT SYSTEM
Company
SNUCONE Co.,LTD.
Model
EINA-4810-7
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K222792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222792000SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.2023-06-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020807311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020807311088000208073118800020807311

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999snuconehq@snucone.com

Regulatory Flags#

DUNS number
688806132
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 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
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
08800020807397SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6010-72026-09-22

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Primary DI, Brand, Company table
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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
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