EMA APPLIANCE

GUDID D84104841

EMA ORAL SLEEP APNEA APPLIANCE

Dyna Flex of Missouri, L.P.

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD84104841
NIH Device Record Keycf30193a-da4e-42e5-94c3-40a0bf4f744a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMA APPLIANCE
Version Model Number0484
Company DUNS006335558
Company NameDyna Flex of Missouri, L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD84104841 [Primary]

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-26

Devices Manufactured by Dyna Flex of Missouri, L.P.

D8410056G19 - ADJUSTABLE HERBST2018-07-06 ORAL SLEEP APNEA APPLIANE
D84100911Z - EZ-Align2018-07-06 Clear Sequential Aligner System
D8410091L1D - EZ-Align2018-07-06 Sequential Aligner (Lower Tray)
D84101101R - Dorsal Appliance2018-07-06 Dorsal oral sleep apnea device (Anti Snoring)
D84101511W - LISA APPLIANCE2018-07-06 LISA ORAL SLEEP APNEA APPLIANCE
D8410091U1M - EZ-Align2018-03-29 Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray
D84104841 - EMA APPLIANCE2018-03-29EMA ORAL SLEEP APNEA APPLIANCE
D84104841 - EMA APPLIANCE2018-03-29 EMA ORAL SLEEP APNEA APPLIANCE
D84104911 - TAP 1 & 32018-03-29 TAP ORAL SLEEP APNEA DEVICE
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