miniMark Dental Implant System 13421411

GUDID 00614950008872

PROVISIONAL BALL O-RING KEEPER TI 6AL-4V ELI

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece
Primary Device ID00614950008872
NIH Device Record Key8766bb26-0c0d-43fa-ba49-db7d8f5d8aa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameminiMark Dental Implant System
Version Model Number13421411
Catalog Number13421411
Company DUNS042763706
Company NameACE SURGICAL SUPPLY CO., INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950008872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00614950008872]

Radiation Sterilization

[00614950008872]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-02

On-Brand Devices [miniMark Dental Implant System]

00614950008872PROVISIONAL BALL O-RING KEEPER TI 6AL-4V ELI
006149500035633.25x15MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
006149500035563.25X15MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
006149500035493.25X15MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
006149500035323.25x13MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
006149500035253.25x13MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
006149500035183.25x13MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
006149500035013.25x11.5MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
006149500034953.25x11.5MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
006149500034883.25x11.5MM LOCATOR W/.5MM CUF IMPLANT TI CP GRADE 4
006149500034713.25x10MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
006149500034643.25x10MM LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
006149500034573.25x10MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
006149500034403.25x8MM LOCATOR W/4MM CUFF IMPLANT TI CP GRADE 4
006149500034333.25x8mm LOCATOR W/2MM CUFF IMPLANT TI CP GRADE 4
006149500034263.25x8MM LOCATOR W/.5MM CUFF IMPLANT TI CP GRADE 4
00614950003419miniMARK PREP 2.3X15MM IMPLANT TI 6AL 4V ELI
00614950003402miniMARK PREP 2.3X13MM IMPLANT TI 6AL 4V ELI
00614950003396miniMARK PREP 2.3X11.5MM IMPLANT TI 6AL 4V ELI
00614950003389miniMARK PREP 2.3X10MM IMPLANT TI 6AL 4V ELI
00614950003372miniMARK 3.25x15MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003365miniMARK 3.25X15MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003358miniMARK 3.25X15MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003341miniMARK 3.25X13MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003334miniMARK 3.25x13MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003327miniMARK 3.25x13MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003310miniMARK 3.25x11.5MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003303miniMARK 3.25x11.5MM 2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003297miniMARK 3.25x11.5MM /.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003280miniMARK 3.25x10MM 4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003273miniMARK 3.25x10MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003266miniMARK 3.25x10MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003259miniMARK 3.25x10MM W/.5MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003242miniMARK 3.25x8MM W/4MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003235miniMARK 3.25x8MM W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003228miniMARK 3.25x8mm W/2MM CUFF LOCATOR IMPLANT TI CP GRADE 4
00614950003211miniMARK 2.9x15MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003204miniMARK 2.9X15MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003198miniMARK 2.9X13MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003181miniMARK 2.9X13MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003174miniMARK 2.9X11.5MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003167miniMARK 2.9X11.5MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003150miniMARK 2.9X10MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003143miniMARK 2.9X10MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003136miniMARK 2.9X8MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003129miniMARK 2.9X8.0MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003113miniMARK 2.9X8.0MM W/4MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003105miniMARK 2.3X15MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
00614950003099miniMARK 2.3X13MM W/4MM CUFF LOCATOR IMPLANT TI6AL 4V ELI
00614950003082miniMARK 2.3X13MM W/2MM CUFF LOCATOR IMPLANT TI 6AL 4V ELI
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