Vivos mRNA

GUDID D82852000140

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD82852000140
NIH Device Record Key656147b5-9cf5-4aff-826f-fa4c99402724
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivos mRNA
Version Model Number5200014
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
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
HIBCCD82852000140 [Primary]

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-14
Device Publish Date2018-04-11

Devices Manufactured by FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

D82850001900 - Twin Block2024-10-21
D82853004020 - Rickonator2024-10-21
D82851001560 - Bioliner Plus2023-02-20
D82852000920 - Vivos mmRNA2021-11-29
D8281330003 - FUJI SC BAND PASTE PAK2018-07-06
D8281330121 - FUJI LC BAND AUTOMIX2018-07-06
D8281330171 - ULTRA BAND LOK CLEAR2018-07-06
D8281330205 - LIGHT BOND PASTE TIPS2018-07-06

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