EMA EMA3D

GUDID 00860015164407

A customized, removable,, and patient-adjustable intraoral device, often fabricated using 3D printing or milling technology, that utilizes interchangeable elastic straps of varying lengths and strengths to advance the mandible forward and open the bite.

New Image Dental Laboratory, Inc.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00860015164407
• NIH Device Record Key: c005f38a-bac4-48c5-b876-cbe0aa53ad0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMA
• Version Model Number: EMA 3D
• Catalog Number: EMA3D
• Company DUNS: 144436490
• Company Name: New Image Dental Laboratory, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860015164407 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2026-02-19
• Device Publish Date: 2026-02-11