TRI-CAM Dental Implant System 30843GL

GUDID 00614950027705

TRI-CAM UCLA GOLD ABUTMENT NP 4.3MM PLATFORM

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece
Primary Device ID00614950027705
NIH Device Record Key18e581f2-997c-439a-93b1-8ee9ec127f18
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRI-CAM Dental Implant System
Version Model Number30843GL
Catalog Number30843GL
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
GS100614950027705 [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 [TRI-CAM Dental Implant System]

00614950008544infinity (PS) TRI-CAM 4.3 x 16mm
00614950008537infinity TRICAM 5.0X16MM 4.3HD
00614950008049UCLA Ø5.0mm 6.0MM WIDE HEXED W/SCREW FOR INFINITY TRICAM
00614950008032UCLA Ø5.0mm 6.0MM WIDE NONHEX W/SCREW FOR INFINITY TRICAM
00614950008025UCLA Ø4.3mm 5.5MM WIDE HEXED W/SCREW FOR INFINITY TRICAM
00614950008018UCLA Ø4.3mm 5.5MM WIDE NONHEX W/SCREW FOR INFINITY TRICAM
00614950008001UCLA Ø3.5mm 4.5MM WIDE HEXED W/SCREW FOR INFINITY TRICAM
00614950007998UCLA Ø3.5mm 4.5MM WIDE NONHEX W/SCREW FOR INFINITY TRICAM
00614950007165infinity (PS) TRI-CAM 5.0 x 13mm, 4.3 PLATFORM
00614950007158infinity (PS) TRI-CAM 5.0 x 11mm, 4.3 PLATFORM
00614950007141infinity (PS) TRI-CAM 5.0 x 10mm, 4.3 PLATFORM
00614950007134infinity (PS) TRI-CAM 5.0 x 8mm, 4.3 PLATFORM
00614950007127infinity (PS) TRI-CAM 4.3 x 13mm, 3.5 PLATFORM
00614950007110infinity (PS) TRI-CAM 4.3 x 11mm, 3.5 PLATFORM
00614950007103infinity (PS) TRI-CAM 4.3 x 10mm, 3.5 PLATFORM
00614950007097infinity (PS) TRI-CAM 4.3 x8mm, 3.5 PLATFORM
00614950028283TRI-CAM Drill 5.0mm x 13mm TL 4 Flutes Tapered
00614950028276TRI-CAM Drill 4.0mm x 16mm TL 4 Flutes Tapered
00614950028245TRI-CAM Drill 3.5mm x 8 TL 4 Flutes Tapered
00614950028238TRI-CAM Drill 3.5mm x 10 TL 4 Flutes Tapered
00614950028221TRI-CAM Drill 3.5mm x 11.5 TL 4 Flutes Tapered
00614950028214TRI-CAM Drill 3.5mm x 13 TL 4 Flutes Tapered
00614950028207TRI-CAM Drill 3.5mm x 16 TL 4 Flutes Tapered
00614950028191TRI-CAM Drill 4.3mm x 8 TL 4 Flutes Tapered
00614950028184TRI-CAM Drill 4.3mm x 10 TL 4 Flutes Tapered
00614950028177TRI-CAM Drill 4.3mm x 11.5 TL 4 Flutes Tapered
00614950028160TRI-CAM Drill 5mm x 8 TL 4 Flutes Tapered
00614950028153TRI-CAM Drill 5mm x 10 TL 4 Flutes Tapered
00614950028146TRI-CAM Drill 5mm x 11.5 TL 4 Flutes Tapered
00614950027712TRI-CAM UCLA GOLD ABUTMENT NP 5.0MM PLATFORM
00614950027705TRI-CAM UCLA GOLD ABUTMENT NP 4.3MM PLATFORM
00614950027699TRI-CAM UCLA GOLD ABUTMENT NP 3.5MM PLATFORM
00614950027682TRI-CAM MULTI-UNIT ABUTMENT STR 4MM H FOR 4.3MM 30 DEG ANGLE
10614950027672TRI-CAM TITANIUM SCREW FOR 3.5MM 5/PKG
00614950027668TRI-CAM MULTI-UNIT ABUTMENT STR 2MM CUFF 3.5MM PLATFORM
00614950027590TRI-CAM MULTI-UNIT ABUTMENT STR 2MM H FOR 4.3MM 17 DEG ANGLE
00614950027583TRI-CAM MULTI-UNIT ABUTMENT STR 2MM H FOR 3.5MM 17 DEG ANGLE
00614950027552TRI-CAM Temporary Abutment, Engaging, 5.0 Platform
00614950027545TRI-CAM Temporary Abutment, Engaging, 3.5 Platform
00614950027538TRI-CAM SCANNING ABUTMENT 5.0MM ANTERIOR
00614950027521TRI-CAM SCANNING ABUTMENT 4.3MM ANTERIOR
00614950027514TRI-CAM SCANNING ABUTMENT 3.5MM POSTERIOR
00614950027507TRI-CAM SCANNING ABUTMENT 3.5MM ANTERIOR
00614950027484TRI-CAM TiBASE ABUTMENT, 5.0 Platform CH 6MM
00614950027477TRI-CAM TiBASE ABUTMENT, 3.5 Platform CH 6MM
00614950027385TRI-CAM MULTI-UNIT ABUTMENT STR 3MM H FOR 4.3MM 17 DEG ANGLE
00614950027330TRI-CAM MULTI-UNIT ABUTMENT STR 1MM CUFF 5.0MM PLATFORM
00614950027323TRI-CAM MULTI-UNIT ABUTMENT STR 1MM CUFF 3.5MM PLATFORM
00614950027309TRI-CAM Temporary Abutment, Non-Engaging, 5.0 Platform
00614950027293TRI-CAM Temporary Abutment, Non-Engaging, 4.3 Platform
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