TS Implant System

GUDID 08800000921204

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800000921204
• NIH Device Record Key: a0ef8cf4-c2d2-4746-995d-9f5a89b1ce48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TS Implant System
• Version Model Number: HGQTA553RHT
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000921204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121585

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800000921204]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-14

On-Brand Devices [TS Implant System]

• 08800000921242: HGQTA453MHT
• 08800000921235: HGQTA453MNT
• 08800000921228: HGQTA455MHT
• 08800000921211: HGQTA455MNT
• 08800000921204: HGQTA553RHT
• 08800000921198: HGQTA553RNT
• 08800000921181: HGQTA555RHT
• 08800000921174: HGQTA555RNT
• 08800000921167: HGATSMT
• 08800000921150: HGATSST