miniMark Dental Implant System 11320805

GUDID 00614950003426

3.25x8MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00614950003426
• NIH Device Record Key: 34a18055-42e4-4945-ad4a-1da6bfb47106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miniMark Dental Implant System
• Version Model Number: 11320805
• Catalog Number: 11320805
• 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: 8 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950003426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093518

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 [miniMark Dental Implant System]

• 00614950008872: PROVISIONAL BALL O-RING KEEPER TI 6AL-4V ELI
• 00614950003563: 3.25x15MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
• 00614950003556: 3.25X15MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
• 00614950003549: 3.25X15MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
• 00614950003532: 3.25x13MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
• 00614950003525: 3.25x13MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
• 00614950003518: 3.25x13MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
• 00614950003501: 3.25x11.5MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
• 00614950003495: 3.25x11.5MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
• 00614950003488: 3.25x11.5MM LOCATOR W/.5MM CUF IMPLANT TI CP GRADE 4
• 00614950003471: 3.25x10MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
• 00614950003464: 3.25x10MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
• 00614950003457: 3.25x10MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
• 00614950003440: 3.25x8MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
• 00614950003433: 3.25x8mm LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
• 00614950003426: 3.25x8MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
• 00614950003419: miniMARK PREP 2.3X15MM IMPLANT TI 6AL 4V ELI
• 00614950003402: miniMARK PREP 2.3X13MM IMPLANT TI 6AL 4V ELI
• 00614950003396: miniMARK PREP 2.3X11.5MM IMPLANT TI 6AL 4V ELI
• 00614950003389: miniMARK PREP 2.3X10MM IMPLANT TI 6AL 4V ELI
• 00614950003372: miniMARK 3.25x15MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003365: miniMARK 3.25X15MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003358: miniMARK 3.25X15MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003341: miniMARK 3.25X13MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003334: miniMARK 3.25x13MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003327: miniMARK 3.25x13MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003310: miniMARK 3.25x11.5MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003303: miniMARK 3.25x11.5MM 2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003297: miniMARK 3.25x11.5MM /.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003280: miniMARK 3.25x10MM 4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003273: miniMARK 3.25x10MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003266: miniMARK 3.25x10MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003259: miniMARK 3.25x10MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003242: miniMARK 3.25x8MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003235: miniMARK 3.25x8MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003228: miniMARK 3.25x8mm W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
• 00614950003211: miniMARK 2.9x15MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003204: miniMARK 2.9X15MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003198: miniMARK 2.9X13MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003181: miniMARK 2.9X13MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003174: miniMARK 2.9X11.5MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003167: miniMARK 2.9X11.5MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003150: miniMARK 2.9X10MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003143: miniMARK 2.9X10MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003136: miniMARK 2.9X8MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003129: miniMARK 2.9X8.0MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003113: miniMARK 2.9X8.0MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003105: miniMARK 2.3X15MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
• 00614950003099: miniMARK 2.3X13MM W/4MM CUFF LOCATOR IMPLANT TI6AL 4V ELI
• 00614950003082: miniMARK 2.3X13MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI