TRICAM Dental Implant System 304360

GUDID 00614985000879

TITANIUM BASE ABUTMENT 6MM CUFF 4.3MM DIAMETER FOR TRICAM

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00614985000879
NIH Device Record Key86d51039-94c8-45d1-ae35-06edb1169e53
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRICAM Dental Implant System
Version Model Number304360
Catalog Number304360
Company DUNS042763706
Company NameACE SURGICAL SUPPLY CO., INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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 Dimensions

Width4.3 Millimeter
Height6 Millimeter
Width4.3 Millimeter
Height6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100614985000879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00614985000879]

Radiation Sterilization


[00614985000879]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2017-01-27

On-Brand Devices [TRICAM Dental Implant System]

00614985000879TITANIUM BASE ABUTMENT 6MM CUFF 4.3MM DIAMETER FOR TRICAM
00614950005338COVER SCREW FOR 5.0MM TRICAM IMPLANT STERILE BLUE 6AL 4V ELI
00614950005321COVER SCREW FOR 4.3MM TRICAM IMPLANT STERILE GOLD 6AL 4V ELI
00614950005314COVER SCREW FOR 3.5MM TRICAM HEX IMPLANT STERILE FUSCHIA 6AL 4V ELI
00614950005307TRICAM 5.0X16MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005291TRICAM 5.0X13MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005284TRICAM 5.0X11.5MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005277TRICAM 5.0X10MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005260TRICAM 5.0X8MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005253TRICAM 4.3X16MM 4.3HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005246TRICAM 4.3X13MM 4.3HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005239TRICAM 4.3X11.5MM 4.3HD INTERN IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005222TRICAM 4.3X10MM 4.3HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE
00614950005215TRICAM 4.3X8MM 4.3HD INTERNAL IMPLANT 6Al-4V ELI
00614950005208TRICAM 3.5X16MM 3.5HD INTERNAL IMPLANT 6Al 4V ELI NOBEL CLONE
00614950005192TRICAM 3.5X13MM 3.5HD INTERNAL IMPLANT 6Al 4V ELI NOBEL CLONE
00614950005185TRICAM 3.5X11.5MM 3.5HD INTER IMPLANT 6Al 4V ELI NOBEL CLONE
00614950005178TRICAM 3.5X10MM 3.5HD INTERNAL IMPLANT 6Al 4V ELI
00614950005161TRICAM 3.5X8MM 3.5HD INTERNAL IMPLANT 6Al-4V ELI
00614950005154PREPABLE ABUTMENT Ø5.0HD 6.0CW 4.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005147PREPABLE ABUTMENT Ø5.0HD 6.0CW 2.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005130PREPABLE ABUTMENT Ø4.3HD 5.5CW 4.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005123PREPABLE ABUTMENT Ø4.3HD 5.5CW 2.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005116PREPABLE ABUTMENT Ø3.5HD 4.5CW 4.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005109PREPABLE ABUTMENT Ø3.5HD 4.5CW 2.0CH W/SCREW TRICAM TI 6Al 4V ELI (NOBEL)
00614950005093HEALING CAP Ø5.0HD 6.0CW 5CH TRICAM CONTOURED TI 6AL 4V ELI
00614950005086HEALING CAP Ø5.0HD 6.0CW 3CH TRICAM CONTOURED TI 6AL 4V ELI
00614950005079HEALING CAP Ø5.0HD 5.2CW 5CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950005062HEALING CAP Ø5.0HD 5.2CW 3CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950005055HEALING CAP Ø5.0HD 5.0CW 5CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950005048HEALING CAP Ø5.0HD 5.0CW 3CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950005031HEALING CAP Ø4.3HD 5.5CW 5.0CH TRICAM CONTOURED TI 6AL 4V ELI
00614950005024HEALING CAP Ø4.3HD 5.5CW 3CH TRICAM CONTOURED TI 6AL 4V ELI
00614950005017HEALING CAP Ø4.3HD 4.5CW 5CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950005000HEALING CAP Ø4.3HD 4.3CW 5CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950004997HEALING CAP Ø4.3HD 4.3CW 3CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950004980HEALING CAP Ø3.5HD 4.5CW 5CH TRICAM CONTOURED TI 6AL 4V ELI
00614950004973HEALING CAP Ø3.5HD 4.5CW 3CH TRICAM CONTOURED TI 6AL 4V ELI
00614950004966HEALING CAP Ø3.5HD TRICAM STRAIGHT TI 6AL 4V ELI
00614950004959HEALING CAP Ø3.5HD 3.5CW 5CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950004942HEALING CAP Ø3.5HD 3.5CW 3CH TRICAM STRAIGHT TI 6AL 4V ELI
00614950028382TRI-CAM Drill 4.3mm x 13mm TL 4 Flutes Tapered
00614950028375TRI-CAM Drill 4.3mm x 16mm TL 4 Flutes Tapered

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