Inclusive®

Basic Information

• Brand Name: Inclusive®
• Primary DI: D745701074PRS00750
• Version / Model: 70-1074-PRS0075
• Catalog Number: 70-1074-PRS0075
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-24
• Public Version: 2
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: eb3b84e9-5460-43df-9760-4e99a7aff5cd
• Distribution End Date: 2024-12-31

Device Description

Inclusive® Full-Arch Scan Body Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61641	Dental implant abutment analog, intraoral-scanning, single-use	An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D745701074PRS00750	HIBCC