SS SA Fixture

GUDID 08800040662068

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08800040662068
• NIH Device Record Key: 2709b0cb-e931-4eb0-b91f-2641911a23e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SS SA Fixture
• Version Model Number: SS3W5007S20
• 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	08800040662068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163557

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: 2022-02-15
• Device Publish Date: 2022-02-07

On-Brand Devices [SS SA Fixture]

• 08800040662426: SS3W5013S20
• 08800040662334: SS3W5011S20
• 08800040662242: SS3W5010S20
• 08800040662150: SS3W5008S20
• 08800040662068: SS3W5007S20
• 08800040661979: SS3W5006S20
• 08800040661757: SS3W4513S20
• 08800040661665: SS3W4511S20
• 08800040661573: SS3W4510S20
• 08800040661481: SS3W4508S20
• 08800040661399: SS3W4507S20
• 08800040660873: SS3R4513S28
• 08800040660866: SS3R4513S18
• 08800040660811: SS3R4511S28
• 08800040660804: SS3R4511S18
• 08800040660750: SS3R4510S28
• 08800040660743: SS3R4510S18
• 08800040660699: SS3R4508S28
• 08800040660682: SS3R4508S18
• 08800040660637: SS3R4507S18
• 08800040660521: SS3R4013S28
• 08800040660514: SS3R4013S18
• 08800040660460: SS3R4011S28
• 08800040660453: SS3R4011S18
• 08800040660408: SS3R4010S28
• 08800040660392: SS3R4010S18
• 08800040660347: SS3R4008S28
• 08800040660330: SS3R4008S18
• 08800040660286: SS3R4007S18
• 08800040660163: SS3R3513S28
• 08800040660156: SS3R3513S18
• 08800040660101: SS3R3511S28
• 08800040660095: SS3R3511S18
• 08800040660040: SS3R3510S28
• 08800040660033: SS3R3510S18
• 08800040659983: SS3R3508S28
• 08800040659976: SS3R3508S18
• 08800040658481: SS2W5013S20
• 08800040658399: SS2W5011S20
• 08800040658306: SS2W5010S20
• 08800040658214: SS2W5008S20
• 08800040658122: SS2W5007S20
• 08800040658030: SS2W5006S20
• 08800040657781: SS2W4515S20
• 08800040657699: SS2W4513S20
• 08800040657606: SS2W4511S20
• 08800040657514: SS2W4510S20
• 08800040657422: SS2W4508S20
• 08800040657330: SS2W4507S20
• 08800040656746: SS2R4515S28