SOVA

Basic Information

• Brand Name: SOVA
• Primary DI: 00858286007646
• Version / Model: Aero
• Company Name: Akervall Technologies, Inc.
• Labeler DUNS: 023254296
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-07
• Public Version: 1
• Public Version Date: 2023-02-15
• Public Version Status: New
• Public Device Record Key: 3624aa5b-29b2-4d20-b1b2-57eb8678d1e1

Device Description

SOVA Aero 1.6mm Ecommerce Packaging

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBR	Mouthguard, Over-The-Counter	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46493	Dental occlusal splint, customizable	A device intended for home-use intended to overlay the occlusal surfaces of the teeth 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). The device is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858286007646	GS1

Premarket Submissions

Submission Number	Supplement Number
K121272	000

Device Sizes

Type	Value	Unit	Text
Depth	1.6	Millimeter