Inclusive

Basic Information

• Brand Name: Inclusive
• Primary DI: D745701047COM00151
• Version / Model: 70-1047-COM0015
• Catalog Number: 70-1047-COM0015
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: eef105bb-40fb-4c7e-9943-99cedc7708a8

Device Description

Inclusive Implant Analog compatible with: Biomet 3i Certain 5.0 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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: No

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
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D745701047COM00151	HIBCC
Unit of Use	D745701047COM00150	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	11	Millimeter