Infinity External Hex System 01409213

GUDID 00614950001293

* CONICAL ABUT HX 4HD 4CH 5.5CW W/SCREW 19509004

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950001293
• NIH Device Record Key: 676e8e92-881e-4e1d-89ab-adbda9fd29bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity External Hex System
• Version Model Number: 01409213
• Catalog Number: 01409213
• 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: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Width: 5.5 Millimeter
• Width: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950001293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954513

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00614950001293]

Radiation Sterilization

[00614950001293]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Infinity External Hex System]

• 00614950004454: * PROSTHETIC SCREW GOLD HEX 1.25MM F/CONICAL UNIV STD ABUT
• 00614950004447: PROSTHETIC RETAIN SCREW 1.25MM F/CIN & UBIV STD ABUT 14TL TI6AL4VELI
• 10614950004437: PROSTHETIC RETAIN SCREW 1.25MM F/CON&UNIV STD ABUT 4.5TL 50/P
• 00614950004423: PROSTHETC RETAIN SCRW 1.25MM F/CON & UNIV STD ABUT 4.5TL
• 00614950004416: CONICAL ABUT RET SCREW 5HD 2CH TI USE 2MM INTERNAL HEX DRIVER
• 00614950004409: CONICAL ABUT RET SCREW 5HD 1CH TI USE 2MM INTERNAL HEX DRIVER
• 00614950004393: CONICAL ABUT RET SCREW 3.5HD 2CH TI USE 2MM INTER HEX DRVR
• 00614950004386: CONICAL ABUT RET SCREW 3.5HD 1CH TI USE 2MM INTER HEX DRVR
• 00614950004379: CONICAL ABUT RET SCREW 4HD 2CH TI USE 2MM INTERNAL HEX DRIVER
• 00614950004362: CONICAL ABUT RET SCREW 4HD 1CH TI USE 2MM INTERNAL HEX DRIVER
• 00614950004355: CONICAL SINGLE STAGE 4HD 7CW HEALING COLLAR W/19522001
• 00614950004348: *CONICAL ABUTMENT SINGLE STAGE HEALING COLLAR W/19522001
• 00614950004331: CONICAL SINGLE STAGE 4HD 5.5CW HEALING COLLAR W/19522001
• 00614950004324: CONICAL SINGLE STAGE 3.5/4HD 4.5CW HEALING COLLAR /19522001
• 00614950004317: STD ABUT SINGLE STAGE 5HD 6.5CW HEALING COLLAR 19522001
• 00614950004300: STD ABUT SINGLE STAGE 4 & 5HD 5.5CW HEALING COLLAR /19522001
• 00614950004294: STD ABUT SINGLE STAGE 3.5/4HD 4.5CW HEALING COLLAR /19522001
• 00614950004287: * HEAL CAP UNIV STD ABUT 7.5CW (TI6AL4VELI) USE WITH SCREW #19521001
• 00614950004270: RETAINING SCREW F/BALL OVER ABUT 4HD 3CH (TI6AL4VELI)
• 00614950004263: RETAINING SCREW F/BALL OVER ABUT 4HD 7CH (TI6AL4VELI)
• 00614950004256: RETAINING SCREW F/BALL OVER ABUT 4HD 5.5CH (TI6AL4VELI)
• 00614950004249: RETAINING SCREW F/BALL OVER ABUT 4HD 4CH (TI6AL4VELI)
• 00614950004232: PROSTHETHIC ATTACH SCREW GOLD 1.25MM HEX
• 00614950004225: LONG DIRECT TRANSFER SCREW F/IMPLANT (TI6AL4VELI)
• 10614950004215: PROSTHETIC & IMPRESSION SCREW TI 1.25MM HEX BULK 50/PKG
• 00614950004201: PROSTHETIC & IMPRES SCREW TI 1.25MM HEX (TI6AL4VELI)
• 00614950004195: LONG DIRECT TRANSFER SCREW F/IMPLANT (TI6AL4VELI)
• 10614950004185: ATTACHMENT & TRANSFER SCREW F/ABUTMENT TI 50/PKG (6AL 4V ELI)
• 00614950004171: ATTACHMENT & TRANSFER TITANIUM SCREW F/ABUTMENT (TI6AL4VELI)
• 00614950004164: ATTACHMENT SCREW TITANIUM F/TAPER ABUT (TI6AL4VELI)
• 00614950004157: RETAINING SCREW F/UNV STD ABUT 3MM (TI6AL4VELI)
• 00614950004140: RETAINING SCREW F/UNV STD ABUT 13MM (TI6AL4VELI)
• 00614950004133: * RETAINING SCREW F/UNV STD ABUT 7MM (TI6AL4VELI)
• 00614950004126: RETAINING SCREW F/UNV STD ABUT 5.5MM (TI6AL4VELI)
• 00614950004119: * RETAINING SCREW F/UNV STD ABUT 4MM (TI6AL4VELI)
• 00614950004102: PREPABLE ABUTMENT RETAINING SCREW 3.5HD TI AL4VELI
• 00614950004096: RETAINING SCREW F/PREPABLE ABUTMENT 4HD (TI6AL4VELI)
• 00614950004089: LOW PROFILE COVER SCREW 6HD IMPLANT
• 00614950004072: LOW PROFILE COVER SCREW FOR 4.75 & 5.75 IMPLANTS STERILE
• 00614950004065: LOW PROFILE COVER SCREW FOR 3.75 & 4MM IMPLANT STERILE
• 00614950004058: LOW PROFILE COVER SCREW 3.5HD STERILE
• 00614950004027: BALL ABUTMENT SCREW INTERNAL 4MM 5.5MM CH W/ORING
• 00614950004010: BALL ABUTMENT SCREW INTERNAL 4MM 4MM CH W/ORING
• 00614950004003: SCREW 3MM FOR INTERNAL BALL ABUTMENT 4MM SYSTEM TI 6AL 4V ELI
• 00614950003938: TAPERED ABUTMENT INTERNAL WAXING SHEATH 4HD SYSTEM
• 00614950003921: CONICAL ABUT PLASTIC CAST SHEATH NHX 5HD 5.5CW (DELRIN)
• 00614950003914: CONICAL ABUT PLASTIC CAST SHEATH NHX 4HD 7CW (DELRIN)
• 00614950003907: CONICAL ABUT PLASTIC CAST SHEATH NHX 3.5/4HD 4.5CW (DELRIN)
• 00614950003891: CASTING SHEATH F/STD ABUT 5HD 7.5CW (DELRIN)
• 00614950003884: * CASTING SHEATH F/STD ABUT 4HD 7CW (DELRIN)