Sports Advantage

GUDID 10190730084597

Mouthguard Plastic Clear .040“ 25 sheets per pack

ORTHO TECHNOLOGY, INC.

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 10190730084597
• NIH Device Record Key: e5687904-67e0-4c7f-95cc-deedc97ef94a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sports Advantage
• Version Model Number: 7500-140
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190730084590 [Primary]
GS1	10190730084597 [Unit of Use]

FDA Product Code

• MQC: Mouthguard, prescription

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: 2025-08-01
• Device Publish Date: 2025-07-24

On-Brand Devices [Sports Advantage]

• 10190730084597: Mouthguard Plastic Clear .040“ 25 sheets per pack
• 10190730084580: Mouthguard Plastic Clear .080“ 25 sheets per pack