SOVA

GUDID 00858286007646

SOVA Aero 1.6mm Ecommerce Packaging

Akervall Technologies, Inc.

Dental occlusal splint, customizable

• Primary Device ID: 00858286007646
• NIH Device Record Key: 3624aa5b-29b2-4d20-b1b2-57eb8678d1e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOVA
• Version Model Number: Aero
• Company DUNS: 023254296
• Company Name: Akervall Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter
• Depth: 1.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858286007646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121272

FDA Product Code

• OBR: Mouthguard, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07