Tri-Nex MC-L-43-4

GUDID D768MCL4340

Conical Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D768MCL4340
• NIH Device Record Key: f4fb8cdd-e1fd-444d-97d3-d33cad513b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Nex
• Version Model Number: MC-L-43-4
• Catalog Number: MC-L-43-4
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)328-3515
• Email: cyoung@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768MCL4340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[D768MCL4340]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-02-11

On-Brand Devices [Tri-Nex]

• D768TSL200: Retention Screw
• D768TSL180: Retention Screw
• D768TCAEL600: Angled Abutment
• D768TCAEL500: Angled Abutment
• D768TCAEL430: Angled Abutment
• D768TCAEL350: Angled Abutment
• D768TCA24EL500: Angled Abutment
• D768TCA24EL430: Angled Abutment
• D768TCA24EL350: Angled Abutment
• D768TCA12EL600: Angled Abutment
• D768TCA12EL500: Angled Abutment
• D768TCA12EL430: Angled Abutment
• D768TCA12EL350: Angled Abutment
• D768PANL600: Passive Abutment
• D768PANL500: Passive Abutment
• D768PANL430: Passive Abutment
• D768PANL350: Passive Abutment
• D768PAMC600: Passive Abutment
• D768PAMC480: Passive Abutment
• D768PAL20G0: Passive Abutment
• D768PAL200: Passive Abutment
• D768PAL18G0: Passive Abutment
• D768PAL180: Passive Abutment
• D768PAEL600: Passive Abutment
• D768PAEL500: Passive Abutment
• D768PAEL430: Passive Abutment
• D768PAEL350: Passive Abutment
• D768MCNL5030: Conical Abutment
• D768MCNL5020: Conical Abutment
• D768MCNL5010: Conical Abutment
• D768MCL5030: Conical Abutment
• D768MCL5020: Conical Abutment
• D768MCL5010: Conical Abutment
• D768MCL4350: Conical Abutment
• D768MCL4340: Conical Abutment
• D768MCL4330: Conical Abutment
• D768MCL4320: Conical Abutment
• D768MCL4317D40: Conical Abutment
• D768MCL4317D20: Conical Abutment
• D768MCL4310: Conical Abutment
• D768MCL3530: Conical Abutment
• D768MCL3520: Conical Abutment
• D768MCL3517D30: Conical Abutment
• D768MCL3517D20: Conical Abutment
• D768MCL3510: Conical Abutment
• D768GSL200: Retention Screw
• D768GSL180: Retention Screw
• D768GCNL600: Gold Sleeve
• D768GCNL500: Gold Sleeve
• D768GCNL430: Gold Sleeve