MS SA Implant System

GUDID 08800040651970

Osstem Implant Co., Ltd.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece

• Primary Device ID: 08800040651970
• NIH Device Record Key: 1544816c-2212-4604-a6c1-5f4aaf3cee6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MS SA Implant System
• Version Model Number: MSD3008S40
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800040651970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122171

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [MS SA Implant System]

• 08800040652854: MSN3013S40
• 08800040652847: MSN3013S25
• 08800040652823: MSN3011S40
• 08800040652816: MSN3011S25
• 08800040652793: MSN3010S40
• 08800040652786: MSN3010S25
• 08800040652762: MSN3008S40
• 08800040652755: MSN3008S25
• 08800040652700: MSN2513S40
• 08800040652687: MSN2513S25
• 08800040652656: MSN2511S40
• 08800040652632: MSN2511S25
• 08800040652601: MSN2510S40
• 08800040652595: MSN2510S25
• 08800040652571: MSN2508S40
• 08800040652564: MSN2508S25
• 08800040652090: MSD3013S40
• 08800040652083: MSD3013S20
• 08800040652052: MSD3011S40
• 08800040652045: MSD3011S20
• 08800040652014: MSD3010S40
• 08800040652007: MSD3010S20
• 08800040651970: MSD3008S40
• 08800040651963: MSD3008S20
• 08800040651895: MSD2513S40
• 08800040651888: MSD2513S20
• 08800040651857: MSD2511S40
• 08800040651840: MSD2511S20
• 08800040651819: MSD2510S40
• 08800040651802: MSD2510S20
• 08800040651772: MSD2508S40
• 08800040651765: MSD2508S20