Inclusive 70-1068-IMP0001

GUDID D745701068IMP00010

Inclusive Mini Implant with Collar 2.2 x 10mm O-Ball

Prismatik Dentalcraft, Inc

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: D745701068IMP00010
• NIH Device Record Key: 4d490ddf-d3a3-4ec0-9f8c-3ab1d5fe235f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inclusive
• Version Model Number: 70-1068-IMP0001
• Catalog Number: 70-1068-IMP0001
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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: true
• 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(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com
• Phone: +1(949)251-1269
• Email: Marilyn.Pourazar@glidewelldental.com

Device Dimensions

• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701068IMP00010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100932

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: 4
• Public Version Date: 2023-08-22
• Device Publish Date: 2015-10-24

On-Brand Devices [Inclusive]

• D745701176COM03150: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 4.8/5.4
• D745701176COM03140: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 4.2
• D745701176COM03130: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 3.6
• D745701176COM03120: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 3.0
• D745701176COM03020: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM03010: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM03000: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02990: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02980: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02970: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02960: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02950: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02940: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02930: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02770: Inclusive Clinical Scanning Abutment, Anterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM02760: Inclusive Clinical Scanning Abutment, Anterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM02750: Inclusive Clinical Scanning Abutment, Anterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM02740: Inclusive Clinical Scanning Abutment, Anterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM02730: Inclusive Clinical Scanning Abutment, Anterior, compatible with: Dentsply Implants Astra Tech I
• D745701176COM02720: Inclusive Clinical Scanning Abutment, Posterior, compatible with: Dentsply Implants Astra Tech
• D745701176COM02710: Inclusive Clinical Scanning Abutment, Posterior, compatible with: Dentsply Implants Astra Tech
• D745701176COM02700: Inclusive Clinical Scanning Abutment, Posterior, compatible with: Dentsply Implants Astra Tech
• D745701176COM02690: Inclusive Clinical Scanning Abutment, Posterior, compatible with: Dentsply Implants Astra Tech
• D745701176COM02680: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02670: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02660: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02650: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02640: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02530: Inclusive Implant Analog compatible with: Dentsply Implants Astra Tech Implant System EV 5.4
• D745701176COM02520: Inclusive Implant Analog compatible with: Dentsply Implants Astra Tech Implant System EV 4.8
• D745701176COM02510: Inclusive Implant Analog compatible with: Dentsply Implants Astra Tech Implant System EV 4.2
• D745701176COM02500: Inclusive Implant Analog compatible with: Dentsply Implants Astra Tech Implant System EV 3.6
• D745701176COM02490: Inclusive Implant Analog compatible with: Dentsply Implants Astra Tech Implant System EV 3.0
• D745701176COM02480: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 4.8/5.4
• D745701176COM02470: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 4.2
• D745701176COM02460: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 3.6
• D745701176COM02450: Inclusive Guide Pin compatible with: Dentsply Implants Astra Tech Implant System EV 3.0
• D745701176COM02440: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02430: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02420: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02410: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02400: Inclusive Bite Verification Cylinder compatible with: Dentsply Implants Astra Tech Implant Syste
• D745701176COM02390: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02380: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02370: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02360: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02350: Inclusive Bite Verification Cylinder, Non-Engaging, compatible with: Dentsply Implants Astra Tec
• D745701176COM02190: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02180: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant
• D745701176COM02170: Inclusive Laboratory Scanning Abutment for Blue Light Scanners compatible with: DENTSPLY Implant