PRIMUS Implant System

GUDID 00810112921328

Biotem AR CEMENTED ABUTMENT(NON-HEX) 6.5Ø X 4.0mm(Cuff:1)

Inosys, Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00810112921328
• NIH Device Record Key: 67cdb57c-c293-475d-90f1-0515f7fe8e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMUS Implant System
• Version Model Number: PBCA R6514N
• 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: true
• Expiration Date: false
• 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	00810112921328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171297

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

[00810112921328]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

On-Brand Devices [PRIMUS Implant System]

• 00810112920338: Biotem AR HEALING ABUTMENTØ4.65 X 4.5 (C:3, H:1.5)
• 00810112920321: Biotem AR HEALING ABUTMENTØ4.65 X 3(C:2, H:1)
• 00810112920314: Biotem AR CLOSING SCREW Standard
• 00810112920307: Biotem AR CLOSING SCREW Narrow
• 00810112921038: BIOTEM AR CEMENTED ABUTMENT(HEX) 6.5mm X 4mm(cuff) X 7mm(height)
• 00810112921021: BIOTEM AR CEMENTED ABUTMENT(HEX) 6.5mm X 3mm(cuff) X 7mm(height)
• 00810112921014: BIOTEM AR CEMENTED ABUTMENT(HEX) 6.5mm X 2mm(cuff) X 7mm(height)
• 00810112921007: BIOTEM AR CEMENTED ABUTMENT(HEX) 6.5mm X 1mm(cuff) X 7mm(height)
• 00810112920994: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:6)
• 00810112920987: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:5)
• 00810112920970: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:4)
• 00810112920963: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:3)
• 00810112920956: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:1)
• 00810112920949: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 5.5mm(Cuff:1)
• 00810112920932: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 4.0mm(Cuff:4)
• 00810112920925: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 4.0mm(Cuff:3)
• 00810112920918: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 4.0mm(Cuff:2)
• 00810112920901: Biotem AR CEMENTED ABUTMENT(HEX)6.5Ø X 4.0mm(Cuff:1)
• 00810112920895: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:4)
• 00810112920888: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:3)
• 00810112920871: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:2)
• 00810112920864: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:1)
• 00810112920857: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:6)
• 00810112920840: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:5)
• 00810112920833: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:4)
• 00810112920826: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:3)
• 00810112920819: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:2)
• 00810112920802: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 5.5mm(Cuff:1)
• 00810112920796: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 4.0mm(Cuff:4)
• 00810112920789: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 4.0mm(Cuff:3)
• 00810112920772: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 4.0mm(Cuff:2)
• 00810112920765: Biotem AR CEMENTED ABUTMENT(HEX)5.5Ø X 4.0mm(Cuff:1)
• 00810112920758: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 7.0mm(Cuff:4)
• 00810112920741: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 7.0mm(Cuff:3)
• 00810112920734: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 7.0mm(Cuff:2)
• 00810112920727: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 7.0mm(Cuff:1)
• 00810112920710: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:6)
• 00810112920703: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:5)
• 00810112920697: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:4)
• 00810112920680: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:3)
• 00810112920673: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:2)
• 00810112920666: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 5.5mm(Cuff:1)
• 00810112920659: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 4.0mm(Cuff:4)
• 00810112920642: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 4.0mm(Cuff:3)
• 00810112920635: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 4.0mm(Cuff:2)
• 00810112920628: Biotem AR CEMENTED ABUTMENT(HEX)4.5Ø X 4.0mm(Cuff:1)
• 00810112920611: Biotem AR CEMENTED ABUTMENT(HEX) 4.5Ø X 7.0mm(Cuff:4)
• 00810112920604: Biotem AR CEMENTED ABUTMENT(HEX) 4.5Ø X 7.0mm(Cuff:3)
• 00810112920598: Biotem AR CEMENTED ABUTMENT(HEX) 4.5Ø X 7.0mm(Cuff:2)
• 00810112920581: Biotem AR CEMENTED ABUTMENT(HEX) 4.5Ø X 7.0mm(Cuff:1)