OCTOGON 50411735

GUDID 00614950027606

OCTOGON MULTI UNIT ABUTMENT 3.5 H 17 DEG ANGLE RP

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950027606
• NIH Device Record Key: 57768719-60fc-4ee1-99cb-cd93c5a1023b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCTOGON
• Version Model Number: 50411735
• Catalog Number: 50411735
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com

Device Dimensions

• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter
• Length: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950027606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103790

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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [OCTOGON]

• 00614950026999: OCTOGON MULTI UNIT ABUTMENT 3.5 H 30 DEG ANGLE RP
• 00614950026982: OCTOGON MULTI UNIT ABUTMENT 2.5 H 17 DEG ANGLE RP
• 00614950026975: OCTOGON MULTI UNIT ABUTMENT 3.5 H STRAIGHT RP
• 00614950026968: OCTOGON MULTI UNIT ABUTMENT 2.5 H STRAIGHT RP
• 00614950026951: OCTOGON MULTI UNIT ABUTMENT 3.5 H 17 DEG ANGLE NP
• 00614950026944: OCTOGON MULTI UNIT ABUTMENT 2.5 H 17 DEG ANGLE NP
• 00614950026937: OCTOGON MULTI UNIT ABUTMENT 3.5MM H STRAIGHT NP
• 00614950026920: OCTOGON MULTI UNIT ABUTMENT 2.5MM H STRAIGHT NP
• 00614950027606: OCTOGON MULTI UNIT ABUTMENT 3.5 H 17 DEG ANGLE RP