ST

Primary DI
08809457205370
Brand
ST
Company
Shinhung MST Co., Ltd.
Model
STR4015LSF
Device description
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221752000StellaShinhung Mst Co., Ltd.2023-06-04DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809457205370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809457205370088094572053708809457205370

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
+821099545139dlwogml831@shinhung.co.kr

Regulatory Flags#

DUNS number
689667152
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806343912961MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2202026-04-13
08806343912978MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3202026-04-13
08806343912985MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4202026-04-13
08806343912992MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5202026-04-13
08806343913005MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6202026-04-13
08806343913012MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1252026-04-13
08806343913029MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2252026-04-13
08806343913036MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3252026-04-13
08806343913043MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4252026-04-13
08806343913050MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5252026-04-13
08806343913067MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6252026-04-13
08806343913074MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1302026-04-13
08806343913081MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2302026-04-13
08806343913098MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3302026-04-13
08806343913104MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4302026-04-13
08806343913111MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5302026-04-13
08806343913128MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6302026-04-13
08806343913135MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1352026-04-13
08806343913142MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2352026-04-13
08806343913159MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3352026-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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