M-PRINT Splint Flex

Basic Information

• Brand Name: M-PRINT Splint Flex
• Primary DI: D7091084051
• Version / Model: M-PRINT Splint flex clear, 1000 g
• Catalog Number: 1084051
• Company Name: Merz Dental GmbH
• Labeler DUNS: 324914910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-07
• Public Version: 1
• Public Version Date: 2022-03-15
• Public Version Status: New
• Public Device Record Key: f6f1018e-7f7f-494a-9343-b666e065a8aa

Device Description

M-PRINT Splint flex clear, 1000 g

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MQC	Mouthguard, Prescription	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
36311	Dental occlusal splint, preformed, reusable	A rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7091084051	HIBCC

Customer Contacts

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