SIS (Stella)

GUDID 08809458315122

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.

Shinhung MST Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809458315122
• NIH Device Record Key: f3992e96-36db-475a-9ef9-eeed83450d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIS (Stella)
• Version Model Number: STDAR40C
• Company DUNS: 689667152
• Company Name: Shinhung MST Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr
• Phone: +821099545139
• Email: dlwogml831@shinhung.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809458315122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221752

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

[08809458315122]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [SIS (Stella)]

• 08806343906953: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906946: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906939: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906922: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906915: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906908: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906892: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906885: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906489: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906472: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906465: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906458: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906441: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906434: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906427: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08806343906410: This product is used to implement fixture, abutment of oral cavity in impression acquisition and
• 08809457205684: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205677: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205660: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205653: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205646: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205639: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205622: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205615: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205608: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205592: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205585: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205578: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205561: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205554: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205547: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205530: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205523: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205516: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205509: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205493: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205486: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205479: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205462: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205455: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205448: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205431: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205424: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205417: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205400: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205394: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205387: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205370: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205363: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support
• 08809457205356: The Stella is intended to be surgically placed in the upper or lower jawbone to provide support