ST

Primary DI
08809458315153
Brand
ST
Company
Shinhung MST Co., Ltd.
Model
STDAR70
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
2023-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
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
08809458315153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809458315153088094583151538809458315153

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
+821099545139dlwogml831@shinhung.co.kr

Regulatory Flags#

DUNS number
689667152
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
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