PRIMUS Implant System

GUDID 00810112921083

Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 5.5mm(Cuff:1)

Inosys, Inc.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00810112921083
• NIH Device Record Key: 94b2afb7-a744-4449-af56-c717c9e72fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMUS Implant System
• Version Model Number: PBCA R4515N
• 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	00810112921083 [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

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

[00810112921083]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-22
• Device Publish Date: 2022-06-14

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)