TRI-CAM Dental Implant System 315010

GUDID 00614950007141

infinity (PS) TRI-CAM 5.0 x 10mm, 4.3 PLATFORM

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00614950007141
• NIH Device Record Key: aaaa8365-6627-447d-a981-ebf48b3669e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRI-CAM Dental Implant System
• Version Model Number: 315010
• Catalog Number: 315010
• 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: 10 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950007141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103790

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 [TRI-CAM Dental Implant System]

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