Infinity External Hex Implant System 404711

GUDID 00614950005529

INFINITY EXTERNAL 4.75X11.5MM Ø5.0HD HEX IMPLANT TI CP GRADE 4

ACE SURGICAL SUPPLY CO., INC.

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

• Primary Device ID: 00614950005529
• NIH Device Record Key: 16b7dc44-a3fe-4d20-88b0-ae78fb68cb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity External Hex Implant System
• Version Model Number: 404711
• Catalog Number: 404711
• 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: true
• 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 Dimensions

• Length: 11.5 Millimeter
• Length: 11.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950005529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954513

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-24

On-Brand Devices [Infinity External Hex Implant System]

• 00614950007042: PREPABLE ABUTMENT Ø6.0MM 2MM HEIGHT [NOBELBIOCARE]
• 00614950007035: IMPRESSION COPING Ø6.0MM UNI-TORX GUIDE PINS GREEN [NOBLEBIOCARE]
• 00614950007028: UNI TORX SCREW BLACK Ø6.0MM [NOBELBIOCARE]
• 00614950007011: SINGLE TOOTH ABUTMENT KIT 6.0= HD (THE STAK) NOBEL BIOCARD
• 00614950007004: CONTOURED HEALING CAP Ø5MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
• 00614950006991: CONTOURED HEALING CAP Ø5MM 3MM HEIGHT 1.25 HEX [NOBELBIOCARE]
• 00614950006984: HEALING CAP Ø5MM 5MM HEIGHT [NOBELBIOCARE]
• 00614950006977: HEALING CAP Ø5MM 3MM HEIGHT [NOBELBIOCARE]
• 00614950006960: HEALING CAP Ø5MM .05MM HEIGHT [NOBELBIOCARE]
• 00614950006953: PREPABLE ABUTMENT Ø5MM 2MM HEIGHT W/UNI TORX SCREW [NOBELBIOCARE]
• 00614950006946: ENGAGING TI BASE F/WAXING SLEEVE & UNI-TORX SCREW Ø5MM BLUE [NOBELBIOCARE]
• 00614950006939: UNI TORX SCREW BLACK Ø5.0MM [NOBELBIOCARE]
• 00614950006922: CONTOURED HEALING CAP Ø4.3MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
• 00614950006915: CONTOURED HEALING CAP Ø4.3MM 3MM HEIGHT 1.25 HEX [NOBELBIOCARE]
• 00614950006908: HEALING CAP Ø4.3MM 5.0 HEIGHT [NOBELBIOCARE]
• 00614950006892: HEALING CAP Ø4.3MM 3MM HEIGHT [NOBELBIOCARE]
• 00614950006885: HEALING CAP Ø4.3MM .05MM HEIGHT [NOBELBIOCARE]
• 00614950006878: PREPABLE ABUTMENT Ø4.3MM 2MM HEIGHT W/SCREW [NOBELBIOCARE]
• 00614950006861: MULTI USE ABUTMENT 1 PIECE Ø4.3MM 1MM HEIGHT TITANIUM [NOBELBIOCARE]
• 00614950006854: ENGAGING TI BASE F/WAXING SLEEVE & UNI TORX-SCREW Ø4.3MM YELLOW[NOBELBIOCARE]
• 00614950006847: UNI TORX SCREW BLACK Ø4.3MM [NOBELBIOCARE]
• 00614950006830: SINGLE TOOTH ABUTMENT KIT 4.3= HD (THE STAK) NOBEL BIOCARD
• 00614950006823: COUNTOURED HEALING CAP Ø3.5MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
• 00614950006816: CONTOURED HEALING CAP Ø3.5MM 3MM HEIGHT 1.25MM HEX [NOBELBIOCARE]
• 00614950006809: HEALING CAP Ø3.5MM 5MM HEIGHT [NOBELBIOCARE]
• 00614950006793: HEALING CAP Ø3.5MM 3MM HEIGHT [NOBELBIOCARE]
• 00614950006786: HEALING CAP Ø3.5MM .05MM HEIGHT [NOBELBIOCARE]
• 00614950006779: PREPABLE ABUTMENT Ø3.5MM 2MM HEIGHT W/UNI TORX SCREW [NOBELBIOCARE]
• 00614950006762: MULTI USE ABUTMENT 1 PIECE Ø3.5MM 3MM HEIGHT TITANIUM [NOBELBIOCARE]
• 00614950006755: MULTI USE ABUTMENT 1 PIECE Ø3.5MM 2MM HEIGHT TITANIUM [NOBELBIOCARE]
• 00614950006748: MULTI USE ABUTMENT 1 PIECE TI Ø3.5MM 1MM HEIGHT [NOBELBIOCARE]
• 00614950006731: ENGAGING TI BASE F/WAXING SLEEVE & UNI-TORX SCREW Ø3.5MM RED [NOBELBIOCARE]
• 00614950006724: SELECT UNI TORX SCREW 3.5MM=D
• 00614950006717: SINGLE TOOTH ABUTMENT KIT 3.5= HD (THE STAK) NOBEL BIOCARE
• 00614950006700: HEALING CAP Ø4.5MM 6.0MM HEIGHT (ZIMMER)
• 00614950006694: HEALING CAP Ø4.5MM 4.0MM HEIGHT (ZIMMER)
• 00614950006687: HEALING CAP Ø4.5MM 2.0MM HEIGHT (ZIMMER)
• 00614950006670: HEALING CAP Ø4.5MM .5MM HEIGHT (ZIMMER)
• 00614950006663: 25°ANGLE PREPABLE ABUTMENT Ø4.5MM WITH .050" HEX SCREW [ZIMMER]
• 00614950006656: ENGAGING TI BASE F/ ZIRCONIA ABUTMENT Ø4.5MM W/SCREW & PIN [ZIMMER]
• 00614950006649: SINGLE TOOTH ABUTMENT KIT 3.5= HD (THE STAK) ZIMMER
• 00614950006632: HEALING CAP Ø3.5MM 6.0MM HEIGHT (ZIMMER)
• 00614950006625: HEALING CAP Ø3.5MM 4.0MM HEIGHT (ZIMMER)
• 00614950006618: HEALING CAP Ø3.5MM 2.0MM HEIGHT (ZIMMER)
• 00614950006601: PREPABLE ABUTMENTS Ø3.5MM WITH .050" HEX SCREW [ZIMMER] 2 PIECE
• 00614950006595: ENGAGING TI BASE F/ ZIRCONIA ABUTMENT Ø3.5MM W/SCREW & PIN (ZIMMER)
• 00614950005543: INFINITY EXTERNAL 4.75X15.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
• 00614950005536: INFINITY EXTERNAL 4.75X13MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
• 00614950005529: INFINITY EXTERNAL 4.75X11.5MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
• 00614950005512: INFINITY EXTERNAL 4.75X10.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4