Orthodontic Screw System

GUDID 08809917110411

Osstem Implant Co., Ltd.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw

• Primary Device ID: 08809917110411
• NIH Device Record Key: a7e626b9-ff0b-4962-9b70-1501df97b099
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthodontic Screw System
• Version Model Number: OSTH1806
• 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
• 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	08809917110411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103105

FDA Product Code

• OAT: Implant, endosseous, orthodontic

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 [Orthodontic Screw System]

• 08809917110497: OSTH1810
• 08809917110459: OSTH1808
• 08809917110411: OSTH1806
• 08809917110374: OSTH1610
• 08809917110329: OSTH1608
• 08809917110244: OSTH1606
• 08809917110169: OSTH1408
• 08809917110114: OSTH1406
• 08809917109835: OSSH1810
• 08809917109798: OSSH1808
• 08809917109750: OSSH1806
• 08809917109705: OSSH1610
• 08809917109668: OSSH1608
• 08809917109620: OSSH1606
• 08809917109576: OSSH1408
• 08809917109552: OSSH1406