Maarc dental - Articulating Paper

Basic Information

• Brand Name: Maarc dental - Articulating Paper
• Primary DI: 08906110440175
• Version / Model: 5521/001
• Catalog Number: 5521/001
• Company Name: SHIVA PRODUCTS
• Labeler DUNS: 737988276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-02
• Public Version: 1
• Public Version Date: 2024-10-10
• Public Version Status: New
• Public Device Record Key: cbddc56b-42fa-4737-b87a-23142d25bce7
• Distribution End Date: 2050-12-31

Device Description

A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks those points on the teeth where the teeth contact during biting and grinding.

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 Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08906110440175	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius