JOHN'S DENTAL LABORATORY INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Anti-Snoring (LRK) (8) Dilator, Nasal (LWF) (4) Device, Jaw Repositioning (LQZ) (3) Wire, Orthodontic (DZC) (2) Mouthguard, Migraine/Tension Headache (OCO) (1)

Premarket Exempt

No Yes

Clear

Luco Hybrid Sleep appliance - 00810002220005 Catalog Number :

Device Description : Vivos DNA Wire, Orthodontic

Device Class : 1

Duns Number: 016649253

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : No

Device Count : 1

Vivos DNA - 00810002220012 Catalog Number :

Device Description : Upper mouth guard, migraine/tension headache, Jaw repositioning device

Device Class : U

Duns Number: 016649253

Premarket Exempt : No

Product Code : OCO

Prescription Use : No

Device Count : 1

Vivos MrNA - 00810002220029 Catalog Number :

Device Description : Anti-SnoringVivos MrNA

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

EMA (Elastic Mandibular Appliance) - 00810002220036 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 1

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK, LQZ, LWF

Prescription Use : No

Device Count : 1

Silencer - 00810002220043 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

TAP (Thornton Adjustable Positioner) - 00810002220050 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 1

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK, LQZ, LWF

Prescription Use : No

Device Count : 1

TAP (Thornton Adjustable Positioner) 3 - 00810002220067 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 1

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK, LQZ, LWF

Prescription Use : No

Device Count : 1

OASYS (Oral/Nasal Airway System) - 00810002220074 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 1

Duns Number: 016649253

Premarket Exempt : No

Product Code : LWF, LRK

Prescription Use : No

Device Count : 1

NAPA (Nocturnal Airway Patency Appliance) - 00810002220081 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Herbst - 00810002220098 Catalog Number :

Device Description : A removable intraoral device designed to alleviate sleep-disordered breathing co

Device Class : 1

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK, DZC

Prescription Use : No

Device Count : 1

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