OSSTEM Implant System - Abutment

GUDID 08809917096760

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809917096760
• NIH Device Record Key: e025036d-6d0f-4e38-845e-e10e19c59c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSTEM Implant System - Abutment
• Version Model Number: TSCHAPM7TH
• 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	08809917096760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161689

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 [OSSTEM Implant System - Abutment]

• 08800000972329: TSQTA5550TH
• 08800000972312: TSQTA5550NTH
• 08800000972305: TSQTA4550TH
• 08800000972299: TSQTA4550RTH
• 08800000972282: TSQTA4550RNTH
• 08800000972275: TSQTA4550NTH
• 08800000972268: TSQTA4515RTH
• 08800000972251: TSQTA4515RNTH
• 08800000972244: TSQTA4050MTH
• 08800000972237: TSQTA4050MNTH
• 08800000972220: TSQTA4015MTH
• 08800000972213: TSQTA4015MNTH
• 08800000972206: TSMA5050P
• 08800000972190: TSMA5050MP
• 08800000972183: TSMA5040P
• 08800000972176: TSMA5040MP
• 08800000972169: TSMA5030P
• 08800000972152: TSMA5030MP
• 08800000972145: TSMA5020P
• 08800000972138: TSMA5020MP
• 08800000972121: TSMA5010P
• 08800000972114: TSMA5010MP
• 08800000972107: TSCHAPR9TH
• 08800000972091: TSCHAPR7TH
• 08800000972084: TSCHAPR5TH
• 08800000972077: TSCHAPM9TH
• 08800000972060: TSCHAPM7TH
• 08800000972053: TSCHAPM5TH
• 08800000972046: RS01
• 08800000972039: RCS01
• 08800000972022: GSZAS6550WH
• 08800000972015: GSZAS6550NWH
• 08800000972008: GSZAS6535WH
• 08800000971995: GSZAS6535NWH
• 08800000971988: GSZAS5550WH
• 08800000971971: GSZAS5550NWH
• 08800000971964: GSZAS5535WH
• 08800000971957: GSZAS5535NWH
• 08800000971940: GSZAS4550WH
• 08800000971933: GSZAS4550NWH
• 08800000971926: GSZAS4535WH
• 08800000971919: GSZAS4535NWH
• 08800000971902: GSZAM4550WH
• 08800000971896: GSZAM4550NWH
• 08800000971889: GSZAM4535WH
• 08800000971872: GSZAM4535NWH
• 08800000971865: GSTTA4530TH
• 08800000971858: GSTTA4530NTH
• 08800000971841: GSTTA4510TH
• 08800000971834: GSTTA4510NTH