Primosplint

Basic Information

• Brand Name: Primosplint
• Primary DI: D831PS100US1
• Version / Model: PS100US
• Company Name: PRIMOTEC LLC
• Labeler DUNS: 153454736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-11-09
• Public Version: 1
• Public Version Date: 2021-11-17
• Public Version Status: New
• Public Device Record Key: dba9a0d8-66de-46fc-b7f6-bd212c2d22f8

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: No
• 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
43025	Dental occlusal splint, custom-made	A rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D831PS100US1	HIBCC
Unit of Use	D831PS100US0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K030832	000