Elastic Mandibular Advancement (EMA) appliance - The Elastic Mandibular Advancement appliance is a - Modern Dental Laboratory (DG) Co., Ltd.

Duns Number:551746187

Device Description: The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic appliance 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.

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More Product Details

Catalog Number

-

Brand Name

Elastic Mandibular Advancement (EMA) appliance

Version/Model Number

003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

c1a5442b-2a11-4e7e-bbae-3180426b4fb0

Public Version Date

November 29, 2019

Public Version Number

1

DI Record Publish Date

November 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MODERN DENTAL LABORATORY (DG) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 24