OCTOGON 50410025

GUDID 00614950026968

OCTOGON MULTI UNIT ABUTMENT 2.5 H STRAIGHT RP

ACE SURGICAL SUPPLY CO., INC.

Dental prosthesis/implant abutment screw

• Primary Device ID: 00614950026968
• NIH Device Record Key: 88a5581f-3979-4750-9c27-73019957e4dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCTOGON
• Version Model Number: 50410025
• Catalog Number: 50410025
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950026968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160132

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

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: 2023-04-14
• Device Publish Date: 2023-04-06

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