FDA.reportPublic FDA data

SNUCONE BONE LEVEL IMPLANT SYSTEM

Primary DI
08800020845115
Brand
SNUCONE BONE LEVEL IMPLANT SYSTEM
Company
SNUCONE Co.,LTD.
Model
ACAMR-50415N
Published
2023-02-17
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
08800020845115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020845115088000208451158800020845115

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
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
08800020802767ABIDING SOLO IMPRESSION CAPASICM-40-42026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPASICM-40-52026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPASICM-40-72026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPASICM-45-42026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPASICM-45-52026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPASICM-45-72026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPASIC-452026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPASIC-552026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPASIC-652026-05-26
08800020802859SOLO LAB ANALOGASLAM-40-42026-05-26
08800020802866SOLO LAB ANALOGASLAM-40-52026-05-26
08800020802873SOLO LAB ANALOGASLAM-40-72026-05-26
08800020802880SOLO LAB ANALOGASLAM-45-42026-05-26
08800020802897SOLO LAB ANALOGASLAM-45-52026-05-26
08800020802903SOLO LAB ANALOGASLAM-45-72026-05-26
08800020802910SOLO LAB ANALOGASLA-452026-05-26
08800020802927SOLO LAB ANALOGASLA-552026-05-26
08800020802934SOLO LAB ANALOGASLA-652026-05-26
08800020802996SOLO PLASTIC COPINGASPCSM-402026-05-26
08800020803009SOLO PLASTIC COPINGASPCSM-452026-05-26

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Primary DI, Brand, Company table
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