SB Anchor

GUDID 08809917096388

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809917096388
• NIH Device Record Key: b18b1e12-d9e7-4393-9476-b2bb6e541e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SB Anchor
• Version Model Number: SMHI425TSR
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809917096388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140600

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-04

On-Brand Devices [SB Anchor]

• 08809917157317: SMHI405TSR
• 08809917096401: SMHI430TSR
• 08809917096388: SMHI425TSR
• 08809917096364: SMHI420TSR
• 08809917096333: SMHI415TSR
• 08809917096302: SMHI410TSR
• 08809917096265: SMHI330TSM
• 08809917096241: SMHI325TSM
• 08809917096227: SMHI320TSM
• 08809917096203: SMHI315TSM
• 08809917096180: SMHI310TSM
• 08809917096173: SMHI305TSM