OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

GUDID 08800000995052

A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit.

Osstem Implant Co.,Ltd.

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• Primary Device ID: 08800000995052
• NIH Device Record Key: 85a70792-7b3a-4b6e-9dcc-034f273fed84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
• Version Model Number: K3
• Company DUNS: 695235881
• 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: false
• Lot Batch: false
• 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	08800000995052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183347

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS]

• 08800000995724: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995052: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995045: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995830: HYMIX