Inclusive®

Basic Information

• Brand Name: Inclusive®
• Primary DI: D745701188COM01150
• Version / Model: 70-1188-COM0115
• Catalog Number: 70-1188-COM0115
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 1
• Public Version Date: 2025-12-09
• Public Version Status: New
• Public Device Record Key: ed83c101-3e34-42db-871f-3ff3bac40305

Device Description

Inclusive® Multi-Unit Coping Screw compatible with: Dentium® NR Line

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, implant, dental, endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D745701188COM01150	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252582	000