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
00850077473005EMA NOW PATIENT STARTER KITSEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473012EMA Serena Patient Starter kitsEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473029EMA 3D PATIENT STARTER KITSEMA SLEEP INCORPORATEDLQZ2026-08-14
00850077473043INDIVIDUAL EMA STRAPS(EMAST13W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473050Individual EMA Straps(EMAST14W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473067Individual EMA Straps(EMAST15W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473081Individual EMA Straps(EMAST17W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473098Individual EMA Straps(EMAST18W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473173Individual EMA Straps(EMAST17Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473180Individual EMA Straps(EMAST18Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473210Individual EMA Straps(EMAST21Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473227Individual EMA Straps(EMAST13B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473234Individual EMA Straps(EMAST14B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473272Individual EMA Straps(EMAST18B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473289Individual EMA Straps(EMAST19B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473296Individual EMA Straps(EMAST20B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14