T1-C

GUDID 08800000995793

Osstem Implant Co.,Ltd.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800000995793
• NIH Device Record Key: 1ca90504-25ec-4c91-8b96-3e23fb793768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T1-C
• Version Model Number: T1-C
• Company DUNS: 694893867
• 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: 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	08800000995793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183475

FDA Product Code

• OAS: X-Ray, Tomography, Computed, 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: 2021-05-06
• Device Publish Date: 2021-04-28

Devices Manufactured by Osstem Implant Co.,Ltd.

• 08800000996264 - OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS: 2025-09-12 The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by
• 08800000996042 - T2 Plus: 2025-05-06 T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray
• 08800000996059 - T2 Plus: 2025-05-06 T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray
• 08800000995977 - OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS: 2025-05-02 The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by
• 08800000995984 - OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS: 2025-05-02 The K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use b
• 08800209338841 - Estar-ZE: 2024-12-11
• 08800209338865 - Estar-ZE: 2024-12-11
• 08800209338889 - Estar-ZE: 2024-12-11