NP-CAST ABUTMENT SYSTEM

GUDID 08800000921358

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800000921358
• NIH Device Record Key: 98378fe9-a340-4bcb-ac5a-31e3f350e41e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NP-CAST ABUTMENT SYSTEM
• Version Model Number: HSCNA60WNT
• 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	08800000921358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121843

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800000921358]

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 [NP-CAST ABUTMENT SYSTEM]

• 08800000921426: HSCNA48ROW
• 08800000921419: HSCNA60WOW
• 08800000921402: HSCNA48RNW
• 08800000921396: HSCNA60WNW
• 08800000921389: HSCNA48ROT
• 08800000921372: HSCNA60WOT
• 08800000921365: HSCNA48RNT
• 08800000921358: HSCNA60WNT
• 08800000921341: HGATSM
• 08800000921334: HGATSS
• 08800000921327: CUABSRW
• 08800000921310: CUABSRT