Inclusive® 70-1172-COM0020

GUDID D745701172COM00200

Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal Ø4.5 mm

Prismatik Dentalcraft, Inc

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D745701172COM00200
• NIH Device Record Key: 3ed1edd2-5058-4199-8800-73b50744e1d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inclusive®
• Version Model Number: 70-1172-COM0020
• Catalog Number: 70-1172-COM0020
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701172COM00200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223496

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-15
• Device Publish Date: 2024-05-07

On-Brand Devices [Inclusive®]

• D745701196COM00060: Inclusive® Multi-Unit Guide Pin compatible with: MIS®
• D745701196COM00050: Inclusive® Multi-Unit Titanium Scan Body compatible with: MIS®
• D745701196COM00040: Inclusive® Multi-Unit Coping Screw compatible with: MIS®
• D745701196COM00030: Inclusive® Multi-Unit Abutment Analog compatible with: MIS®
• D745701196COM00020: Inclusive® Multi-Unit Coping 8 mmH compatible with: MIS®
• D745701196COM00010: Inclusive® Multi-Unit Coping 4.5 mmH compatible with: MIS®
• D745701194COM00330: Inclusive® Implant Analog compatible with: MIS® C1 WP
• D745701194COM00320: Inclusive® Implant Analog compatible with: MIS® C1 SP
• D745701194COM00310: Inclusive® Implant Analog compatible with: MIS® C1 NP
• D745701194COM00300: Inclusive® Titanium Scan Body compatible with: MIS® C1 WP
• D745701194COM00290: Inclusive® Titanium Scan Body compatible with: MIS® C1 SP
• D745701194COM00280: Inclusive® Titanium Scan Body compatible with: MIS® C1 NP
• D745701194COM00270: Inclusive® Guide Pin compatible with: MIS® WP
• D745701194COM00260: Inclusive® Guide Pin compatible with: MIS® SP
• D745701194COM00250: Inclusive® Guide Pin compatible with: MIS® NP
• D745701194COM00240: Inclusive® Titanium Screw compatible with: MIS® WP
• D745701194COM00230: Inclusive® Titanium Screw compatible with: MIS® SP
• D745701194COM00220: Inclusive® Titanium Screw compatible with: MIS® NP
• D745701194COM00210: Inclusive® Bite Verification Cylinder, Non-Engaging, compatible with: MIS® C1 WP
• D745701194COM00200: Inclusive® Bite Verification Cylinder, Non-Engaging, compatible with: MIS® C1 SP
• D745701194COM00190: Inclusive® Bite Verification Cylinder, Non-Engaging, compatible with: MIS® C1 NP
• D745701194COM00180: Inclusive® Bite Verification Cylinder compatible with: MIS® C1 WP
• D745701194COM00170: Inclusive® Bite Verification Cylinder compatible with: MIS® C1 SP
• D745701194COM00160: Inclusive® Bite Verification Cylinder compatible with: MIS® C1 NP
• D745701194COM00150: Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 WP
• D745701194COM00140: Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 SP
• D745701194COM00130: Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 NP
• D745701194COM00120: Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 WP
• D745701194COM00110: Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 SP
• D745701194COM00100: Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 NP
• D745701194COM00090: Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 WP
• D745701194COM00080: Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 SP
• D745701194COM00070: Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 NP
• D745701194COM00060: Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 WP
• D745701194COM00050: Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 SP
• D745701194COM00040: Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 NP
• D745701194COM00030: Inclusive® Titanium Abutment Blank compatible with: MIS® C1 WP
• D745701194COM00020: Inclusive® Titanium Abutment Blank compatible with: MIS® C1 SP
• D745701194COM00010: Inclusive® Titanium Abutment Blank compatible with: MIS® C1 NP
• D745701172COM00550: Inclusive® Multi-Unit Guide Pin compatible with: BioHorizons® Tapered Internal
• D745701172COM00540: Inclusive® Multi-Unit Titanium Scan Body compatible with: BioHorizons® Tapered Internal
• D745701172COM00530: Inclusive® Multi-Unit Coping Screw compatible with: BioHorizons® Tapered Internal
• D745701172COM00520: Inclusive® Multi-Unit Abutment Analog compatible with: BioHorizons® Tapered Internal
• D745701172COM00510: Inclusive® Multi-Unit Coping 8 mmH compatible with: BioHorizons® Tapered Internal
• D745701172COM00500: Inclusive® Multi-Unit Coping 4.5 mmH compatible with: BioHorizons® Tapered Internal
• D745701172COM00490: Inclusive® Implant Analog compatible with: BioHorizons® Tapered Internal Ø5.7 mm
• D745701172COM00480: Inclusive® Implant Analog compatible with: BioHorizons® Tapered Internal Ø4.5 mm
• D745701172COM00470: Inclusive® Implant Analog compatible with: BioHorizons® Tapered Internal Ø3.5 mm
• D745701172COM00460: Inclusive® Implant Analog compatible with: BioHorizons® Tapered Internal Ø3.0 mm
• D745701172COM00450: Inclusive® Titanium Scan Body compatible with: BioHorizons® Tapered Internal Ø5.7 mm