evertis

GUDID 08806343924414

This product is a device that is attached to a surgical guide and used to guide a drill to implant a dental implant fixture at a specified location, direction, and depth.

Shinhung MST Co., Ltd.

Dental implantation drilling template guide-sleeve

• Primary Device ID: 08806343924414
• NIH Device Record Key: 0eebb08e-220b-4cc8-8815-590c239ed843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: evertis
• Version Model Number: SSG53P
• Company DUNS: 689667152
• Company Name: Shinhung MST Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr
• Phone: +82337301913
• Email: jssong@shinhung.co.kr

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806343924414 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

[08806343924414]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [evertis]

• 08806343924605: This product is a device that is attached to a surgical guide and used to guide a drill to impla
• 08806343924414: This product is a device that is attached to a surgical guide and used to guide a drill to impla