Elastic Mandibular Advancement (EMA) appliance (UDI 003)
Manufactured by Modern Dental Laboratory (DG) Co., Ltd.
Device Regulatory Overview
The Elastic Mandibular Advancement (EMA) appliance (Model/Catalog Number: 003) is a medical device manufactured by Modern Dental Laboratory (DG) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification LRK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 003
- Product Code / EMDN
- LRK
- Device Name
- The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic appliance. The modifications are:1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thickness. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in fixed position, but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.
- Database Sync Date
- 2026-08-09 09:06:41
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Elastic Mandibular Advancement (EMA) appliance?
The registered manufacturer of record for Elastic Mandibular Advancement (EMA) appliance is Modern Dental Laboratory (DG) Co., Ltd..
What is the Primary UDI-DI identifier for Elastic Mandibular Advancement (EMA) appliance?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 003.
What classification code is assigned to this device?
This device is registered under product classification code LRK.
Similar Classification Devices (LRK)
Other Devices by Modern Dental Laboratory (DG) Co., Ltd.
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