OCT ITS-TC1NE

GUDID D768ITSTC1NE0

Temp Sleeve

KEYSTONE DENTAL, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D768ITSTC1NE0
• NIH Device Record Key: 30b96968-41b1-499f-8f18-6d12eaefd455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCT
• Version Model Number: ITS-TC1NE
• Catalog Number: ITS-TC1NE
• 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	D768ITSTC1NE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061169

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-02-11

On-Brand Devices [OCT]

• D768TSITPA0: Abutment Screw
• D768TSIT20: Retention Screw
• D768TSAF550: Solid Abutment
• D768TSAF40: Solid Abutment
• D768TSA6550: Solid Abutment
• D768TSA640: Solid Abutment
• D768SYN620DF60: Angled Abutment
• D768SYN620DC60: Angled Abutment
• D768SYN615DF60: Angled Abutment
• D768SYN615DC60: Angled Abutment
• D768SYN60: Angled Abutment
• D768SYN20DF60: Angled Abutment
• D768SYN20DC60: Angled Abutment
• D768SYN15DF60: Angled Abutment
• D768SYN15DC60: Angled Abutment
• D768ITSPANE0: Passive Abutment
• D768ITSPA0: Passive Abutment
• D768ITSGC1NE0: Gold Sleeve
• D768ITSGC10: Gold Sleeve
• D768ITS6PANE0: Passive Abutment
• D768ITS6PA0: Passive Abutment
• D768TT660: Healing Abutment
• D768TT650: Healing Abutment
• D768TT630: Healing Abutment
• D768TT620: Healing Abutment
• D768TT610: Healing Abutment
• D768TT600: Cover Screw
• D768TT450: Healing Abutment
• D768TT30: Healing Abutment
• D768TT20: Healing Abutment
• D768TT10: Healing Abutment
• D768TT00: Cover Screw
• D768PCAP6550: Healing Cap
• D768PCAP6400: Healing Cap
• D768ITSTC1NE0: Temp Sleeve
• D768ITSTC10: Temp Sleeve
• D768ITS6TC1NE0: Temp Sleeve
• D768ITS6TC10: Temp Sleeve