FDA.reportPublic FDA data

Vivos DNA-Lower

Primary DI
00810002220159
Brand
Vivos DNA-Lower
Company
JOHN'S DENTAL LABORATORY INC
Model
3014680794
Device description
Lower mouth guard, migraine/tension headache, Jaw repositioning device
Published
2022-06-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
OCOMouthguard, Migraine/Tension Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCOMouthguard, Migraine/Tension HeadacheUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160477000The Luco Hybrid OSA ApplianceLuco Hybrid Osa Appliance, Inc.2016-07-29OCO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810002220159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810002220159008100022201598100022201590810002220159

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016649253
Device count
1
Serial number
true
Manufacturing date on label
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
00810002220111mmRNA appliance30146807942022-02-04
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
00860015852106Myoaligner®MYOHEALTH TECHNOLOGIES, INCOCO2026-05-15
00860313000827NTI-tss PlusKELLER LABORATORIES, INC.OCO2026-04-21
00860013500733Custom Night GuardGrindGuard Inc.OCO2026-03-05
00860013500740Custom Night GuardGrindGuard Inc.OCO2026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INCOCO2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCOCO2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCOCO2026-03-05
00860013500702Custom Night GuardGrindGuard Inc.OCO2025-03-17
07540204000077Panthera Occlusal Appliance - SinglePanthera Dentaire IncOCO2024-10-28
00860005753086Nylon Nightguard/Occlusal ApplianceSERENA SLEEP SOLUTIONS LLCOCO2024-06-05
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCOCO2023-03-28
00810002220012Vivos DNAJOHN'S DENTAL LABORATORY INCOCO2020-09-08