CAMouflage

Basic Information

• Brand Name: CAMouflage
• Primary DI: D745701000CMN00341
• Version / Model: 70-1000-CMN0034
• Catalog Number: 70-1000-CMN0034
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 3
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: 58902379-9db7-431f-93d7-44e5cefd5f2a

Device Description

CAMouflage NOW Milling Blocks; GD-Mandrel; A3 HT; 14 (5 units)

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: Labeling does not contain MRI Safety Information
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47906	Custom-made dental composite resin kit	A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D745701000CMN00341	HIBCC
Unit of Use	D745701000CMN00340	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162537	000