FDA.reportPublic FDA data

mmRNA appliance

Primary DI
00810002220111
Brand
mmRNA appliance
Company
JOHN'S DENTAL LABORATORY INC
Model
3014680794
Device description
The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. Itconsists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep.
Published
2022-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQZDevice, Jaw Repositioning
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQZDevice, Jaw RepositioningDental2
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210203000mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)2021-08-19LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810002220111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810002220111008100022201118100022201110810002220111

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016649253
Device count
1
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810002220104Abutment/Implant30146807942020-11-18
00810002220272Herbst30146807942023-04-05
00810002220258The Silencer30146807942023-04-03
00810002220265NAPA (Nocturnal Airway Patency Appliance)30146807942023-04-03
00810002220241The Luco Hybrid OSA Appliance30146807942023-03-28
00810002220234Vivos mRNA30146807942023-03-28
00810002220166Vivos Dorsal mRNA 30146807942023-02-14
00810002220159Vivos DNA-Lower30146807942022-06-13
00810002220012Vivos DNA30146807942020-09-08
00810002220173KeyPrint KeySplint Soft30146807942023-04-04
00810002220128Digital Denture30146807942020-11-25
00810002220098Herbst30146807942020-09-23
00810002220142Vivos mmRNA appliance30146807942023-03-28
00810002220210OASYS (Oral/Nasal Airway System)30146807942023-03-28
00810002220203EMA (Elastic Mandibular Advancement appliance)30146807942023-03-27
00810002220043Silencer30146807942020-09-23
00810002220081NAPA (Nocturnal Airway Patency Appliance)30146807942020-09-23
00810002220050TAP (Thornton Adjustable Positioner)30146807942020-09-23
00810002220067TAP (Thornton Adjustable Positioner) 330146807942020-09-23
00810002220074OASYS (Oral/Nasal Airway System)30146807942020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D854413871967328267319ApnoDentSELANE PRODUCTS, INC.LRK2026-05-29
00860005753093Serena SureSERENA SLEEP SOLUTIONS LLCLRK2026-05-20
00851085006247Nylon flexTAP Oral ApplianceAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
00851085006254Nylon flexTAP Oral Appliance KitAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLQZ2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LQZ2026-04-17
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473777EMA Dual LaminateEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473791EMA 3DEMA SLEEP INCORPORATEDLQZ2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
00860008847522KAVA DORSAL DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
00860008847539KAVA HERBST DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
D775CSAA0NAPA ApplianceGreat Lakes Dental Technologies, Ltd.LQZ2026-04-13
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06