Bone Level Fixture

GUDID 00810112920154

Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 11.5mm

Inosys, Inc.

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: 00810112920154
• NIH Device Record Key: 6bad59f6-5cd4-46e9-ab8c-979b68849594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Fixture
• Version Model Number: PBF 4511S
• Company DUNS: 101803383
• Company Name: Inosys, Inc.
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810112920154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190641

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: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [Bone Level Fixture]

• 00810112920291: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 15.0mm
• 00810112920284: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 13.0mm
• 00810112920277: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 11.5mm
• 00810112920260: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 10.0mm
• 00810112920253: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 8.5mm
• 00810112920246: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø6.0 X 7.5mm
• 00810112920239: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 15.0mm
• 00810112920222: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 13.0mm
• 00810112920215: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 11.5mm
• 00810112920208: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 10.5mm
• 00810112920192: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 8.5mm
• 00810112920185: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø5.1 X 7.5mm
• 00810112920178: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 15.0mm
• 00810112920161: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 13.0mm
• 00810112920154: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 11.5mm
• 00810112920147: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 10.0mm
• 00810112920130: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 8.5mm
• 00810112920123: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 7.5mm
• 00810112920116: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 15.0mm
• 00810112920109: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 13.0mm
• 00810112920093: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 11.5mm
• 00810112920086: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 10.0mm
• 00810112920079: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 8.5mm
• 00810112920062: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.2 X 7.5mm
• 00810112920055: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 15.0mm
• 00810112920048: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 13.0mm
• 00810112920031: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 11.5mm
• 00810112920024: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 10.0mm
• 00810112920017: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 8.5mm
• 00810112920000: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø3.7 X 7.5mm