INFINTY EXTERNAL HEX SYSTEM 50MUA23

GUDID 00614950027750

OCTOGON MULTI UNIT ABUTMENT GUIDE PIN WITH SCS APEX

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece
Primary Device ID00614950027750
NIH Device Record Keyb45b5f5d-4662-4973-aaa8-4fa040e3658c
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINTY EXTERNAL HEX SYSTEM
Version Model Number50MUA23
Catalog Number50MUA23
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
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com
Phone+1(508)588-3100
Emailregulatoryandquality@acesurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950027750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [INFINTY EXTERNAL HEX SYSTEM]

00614950028597INTERNAL HEX SCANNING ABUTMENT. 4.5 MM PLAT ANT CH 13MM TITAN
00614950028566Clinical Scan Body Ti
00614950028559Clinical Scan Body Ti
00614950028542Clinical Scan Body Ti
00614950028535Clinical Scan Body Ti
00614950028269infinity External Hex Surgical Kit
00614950028252infinity Dental Implant System TRI-CAM Surgical Kit
00614950028139Clinical Scan Body Posterior
00614950028122Clinical Scan Body Posterior
00614950028115Clinical Scan Body Posterior
00614950028108Clinical Scan Body Posterior
00614950028092Clinical Scan Body Anterior
00614950028085Clinical Scan Body Anterior
00614950027903INTERNAL HEX OPEN TRAY IMPRESSION COPING 4.5 STRAIGHT
00614950027897INTERNAL HEX OPEN TRAY IMPRESSION COPING 3.5 STRAIGHT
00614950027880INTERNAL HEX CLOSED TRAY IMPRESSION COPING 4.5 STRAIGHT
00614950027873INTERNAL HEX CLOSED TRAY IMPRESSION COPING 3.5 STRAIGHT
00614950027798OCTOGON MULTI-UNIT ABUTMENT PROSTHETIC SCREW FOR SCS
00614950027781MUA GOLD/PLASTIC COPING NO SCREW
00614950027774MULTI-UNIT DRIVER
00614950027767MUA SCANNING ABUTMENT W/PROSTHETIC SCREW
00614950027750OCTOGON MULTI UNIT ABUTMENT GUIDE PIN WITH SCS APEX
00614950027743OCTOGON MULTI UNIT TITANIUM TEMPORARY FOR SCS
00614950027736OCTOGON MULTI UNIT ABUTMENT SCREW AMGLED NARROW/REGULAR
00614950027729OCTAGON TITANIM ABUTMENT BL/NC (NP)
00614950027651MUA INTERNAL HEX PROSTHETIC ANGLED ABUTMENT SCREW
00614950027644INTERNAL HEX MULTI-UNIT GUIDE PIN WITH .050 HEX
00614950027637INTERNAL HEX MULTI UNIT ABUTMENT 4.5 PLATFORM X2MM H
00614950027620INTERNAL HEX 30 DEG MULTI UNIT ABUTMENT 4.5 X3MM H
00614950027613INTERNAL HEX LAB SCREW PACKGAGE OF 5
00614950027576INTERNAL HEX MULTI-UNIT ABUTMENT 4.5 PLATFORM X3MM H. 17 DEG ANG
00614950027569INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X1MM H. STRAIGHT
00614950027491INTERNAL HEX SCANNING ABUTMUNT 3.5MM PLATFORM 6.5MM H
00614950027460INTERNAL HEX TEMPORARY ABUTMENT NON-ENGAGING 4.5MM
00614950027453INTERNAL HEX TEMPORARY ABUTMENT ENGAGING 4.5MM
00614950027446INTERNAL HEX TEMPORARY ABUTMENT ENGAGING 3.5MM
00614950027439MUA INTERNAL HEX PROSTHETIC SCREW
00614950027422MUA IMPRESSION COPING CLOSED TRAY
00614950027415OCTAGON TITANIUM SCREW FOR TITANIUM BASE BL/RC (RP)
00614950027408OCTAGON TITANIUM SCREW FOR TITANIUM BASE BL/NC (NP)
00614950027392OCTAGON TITANIM ABUTMENT BL/RC (RP)
00614950027378INTRNAL HEX UCLA GOLD ABUTMENT 4.5MM PLATFORM ENGAGING
00614950027361INTRNAL HEX UCLA GOLD ABUTMENT 3.5MM PLATFORM ENGAGING
00614950027354INTERNAL HEX 30 DEG MULTI UNIT ABUTMENT 3.5 X3MM H
00614950027347INTERNAL HEX 17 DEG MULTI UNIT ABUTMENT 3.5 X2MM H
00614950027316INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X3MM H. 17 DEG ANG
00614950027170MUA IMPRESSION COPING OPEN TRAY
00614950027101MUA ANALOG
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