Infinity Internal Hex System 2083545

GUDID 00614950008063

UCLA Ø3.5mm 4.5MM WIDE HEXED W/SCREW FOR IHEX

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950008063
• NIH Device Record Key: bb655530-13dc-408e-8e5d-d9ef70c50a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity Internal Hex System
• Version Model Number: 2083545
• Catalog Number: 2083545
• 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: true
• 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: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950008063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102981

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

On-Brand Devices [Infinity Internal Hex System]

• 00614950008254: infinity Internal 4.7 x 6.00 mm 4.5HD Hex Implant
• 00614950008087: UCLA Ø4.5mm 5.5MM WIDE HEXED W/SCREW FOR INFINITY IHEX
• 00614950008070: UCLA Ø4.5mm 5.5MM WIDE NONHEX W/SCREW FOR INFINITY IHEX
• 00614950008063: UCLA Ø3.5mm 4.5MM WIDE HEXED W/SCREW FOR IHEX
• 00614950008056: UCLA Ø3.5mm 4.5MM WIDE NON HEX FOR INFINITY INTERNAL HEX
• 00614950007202: infinity (PS) INTERNAL HEX 4.7 x 13mm, 3.5 PLATFORM
• 00614950007196: infinity (PS) INTERNAL HEX 4.7 x 11.5mm, 3.5 PLATFORM
• 00614950007189: infinity (PS) INTERNAL HEX 4.7 x 10mm, 3.5 PLATFORM
• 00614950007172: infinity (PS) INTERNAL HEX 4.7 x 8mm, 3.5 PLATFORM
• 00614950004850: COVER SCREW FOR 4.5MM INTERNAL HEX IMPLANT STERILE 6AL 4V ELI
• 00614950004843: COVER SCREW FOR 3.5MM INTERNAL HEX IMPLANT STERILE GREEN 6AL 4V ELI
• 00614950004836: infinity INTERNAL 5.1x16.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004829: infinity INTERNAL 5.1x13.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004812: infinity INTERNAL 5.1x11.5MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004805: infinity INTERNAL 5.1x10.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004799: infinity INTERNAL 5.1x8.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004782: infinity INTERNAL 5.1x6.0MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004775: infinity INTERNAL 4.7X16MM Ø4.5HD HEX IMPLANT 6AI 4V ELI
• 00614950004768: infinity INTERNAL 4.7x13MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004751: infinity INTERNAL 4.7x11.5MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004744: infinity INTERNAL 4.7x10MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004737: infinity INTERNAL 4.7x8MM Ø4.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004720: infinity INTERNAL 4.1X16MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004713: infinity INTERNAL 4.1X13MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004706: infinity INTERNAL 4.1x11.5MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004690: infinity INTERNAL 4.1x10MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004683: infinity INTERNAL 4.1x8.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004676: infinity INTERNAL 4.1x6.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004669: infinity INTERNAL 3.7x16MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004652: infinity INTERNAL 3.7x13MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004645: infinity INTERNAL 3.7x11.5MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004638: infinity INTERNAL 3.7x10MM Ø3.5 HEX IMPLANT 6AL-4V ELI
• 00614950004621: infinity INTERNAL 3.7x8.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI
• 00614950004614: PREPABLE ABUTMENT Ø4.5HD 5.5CW 4.0CH W/SCREW INTERNAL HEX TI 6Al 4V ELI (ZIMMER)
• 00614950004607: PREPABLE ABUTMENT Ø4.5HD 5.5CW 2.0CH W/SCREW IHEX TI 6Al 4V ELI (ZIMMER)
• 00614950004591: PREPABLE ABUTMENT Ø3.5HD 4.5CW 4.0CH W/SCREW INTERNAL HEX TI 6Al 4V ELI (ZIMMER)
• 00614950004584: PREPABLE ABUTMENT Ø3.5HD 4.5CW 2.0CH W/SCREW INTERNAL HEX TI 6Al 4V ELI (ZIMMER)
• 00614950004577: HEALING CAP Ø4.5HD 6.5CW 5CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004560: HEALING CAP Ø4.5HD 6.5CW 3CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004553: HEALING CAP Ø4.5HD 5.5CW 5CH INTERNAL HEX CONTOURED PURPLE TI 6Al 4V ELI
• 00614950004546: HEALING CAP Ø4.5HD 5.5CW 3CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004539: HEALING CAP Ø4.5HD 4.7CW 5CH INTERNAL HEX STRAIGHT TI 6Al 4V ELI
• 00614950004522: HEALING CAP Ø4.5HD 4.7CW 3CH INTERNAL HEX STRAIGHT TI 6Al 4V ELI
• 00614950004515: HEALING CAP Ø3.5HD 5.5CW 5CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004508: HEALING CAP Ø3.5HD 5.5CW 3CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004492: HEALING CAP Ø3.5HD 4.5CW 5CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004485: HEALING CAP Ø3.5HD 4.5CW 3CH INTERNAL HEX CONTOURED TI 6Al 4V ELI
• 00614950004478: HEALING CAP Ø3.5HD 3.7CW 5CH INTERNAL HEX STRAIGHT TI 6Al 4V ELI
• 00614950004461: HEALING CAP Ø3.5HD 3.7CW 3CH INTERNAL HEX (STRAIGHT) TI 6Al 4V ELI
• 00614950009497: infinity INTERNAL 3.7x6.0MM Ø3.5HD HEX IMPLANT 6AL-4V ELI