FDA.reportPublic FDA data

SNUCONE BONE LEVEL IMPLANT SYSTEM

Primary DI
08800020854759
Brand
SNUCONE BONE LEVEL IMPLANT SYSTEM
Company
SNUCONE Co.,LTD.
Model
AF+B-5809S
Published
2023-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
08800020854759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020854759088000208547598800020854759

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28