enCore Night Guard

GUDID 00860015217721

ENCORE LABORATORY LLC

Custom-made mouthguard

• Primary Device ID: 00860015217721
• NIH Device Record Key: d252357a-252f-438f-8dbe-20a42ae36f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enCore Night Guard
• Version Model Number: Hard
• Company DUNS: 128114843
• Company Name: ENCORE LABORATORY LLC
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860015217721 [Primary]

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: 2026-03-10
• Device Publish Date: 2026-03-02

On-Brand Devices [enCore Night Guard]

• 00860015217707: Hybrid
• 00860015217738: Soft
• 00860015217721: Hard