Inclusive 70-1147-COM0046

GUDID D745701147COM00460

Inclusive Titanium Abutment 6 mmH compatible with: Hiossen HG System Standard

James R. Glidewell, Dental Ceramics, Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D745701147COM00460
• NIH Device Record Key: fd4db8f9-ee1a-44ea-81dc-86ee6d78cf2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inclusive
• Version Model Number: 70-1147-COM0046
• Catalog Number: 70-1147-COM0046
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: false
• 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(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701147COM00460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151375

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam Sterilization

[D745701147COM00460]

Moist Heat or Steam 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: 2016-10-07

On-Brand Devices [Inclusive]

• D745701176COM02000: Inclusive® Implant Analog compatible with: Dentsply Implants Astra Tech Implant System® EV 5.4
• D745701176COM01990: Inclusive® Implant Analog compatible with: Dentsply Implants Astra Tech Implant System® EV 4.8
• D745701176COM01980: Inclusive® Implant Analog compatible with: Dentsply Implants Astra Tech Implant System® EV 4.2
• D745701176COM01970: Inclusive® Implant Analog compatible with: Dentsply Implants Astra Tech Implant System® EV 3.6
• D745701176COM01960: Inclusive® Implant Analog compatible with: Dentsply Implants Astra Tech Implant System® EV 3.0
• D745701172COM00050: Inclusive® Laboratory Scanning Abutment for Blue Light Scanners compatible with: BioHorizons®
• D745701172COM00040: Inclusive® Implant Analog compatible with: BioHorizons® Implant System 3.0
• D745701172COM00030: Inclusive® Laboratory Scanning Abutment compatible with: BioHorizons® Implant System 3.0
• D745701176COM03330: Inclusive 15° Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra T
• D745701176COM03320: Inclusive 15° Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra T
• D745701176COM03310: Inclusive 15° Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra T
• D745701176COM03300: Inclusive 15° Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra T
• D745701176COM03290: Inclusive 15° Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Te
• D745701176COM03280: Inclusive 15° Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Te
• D745701176COM03270: Inclusive 15° Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Te
• D745701176COM03260: Inclusive 15° Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Te
• D745701176COM03250: Inclusive 15° Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Te
• D745701176COM03240: Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM03230: Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM03220: Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM03210: Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM03200: Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Tech Im
• D745701176COM03190: Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Tech Im
• D745701176COM03180: Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Tech Im
• D745701176COM03170: Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Tech Im
• D745701176COM03160: Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Dentsply Implants Astra Tech Im
• D745701176COM02920: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02910: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02900: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02890: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02880: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02870: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02860: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02850: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02840: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02830: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02820: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech
• D745701176COM02810: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech
• D745701176COM02800: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech
• D745701176COM02790: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech
• D745701176COM02780: Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech
• D745701176COM02340: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02330: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02320: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02310: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02300: Inclusive Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System E
• D745701176COM02290: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02280: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02270: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System
• D745701176COM02260: Inclusive Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System