Dyna Flex of Missouri, L.P.

Dyna Flex of Missouri, L.P.

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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) (6) Aligner, Sequential (NXC) (3) Bracket, Ceramic, Orthodontic (NJM) (1)

Premarket Exempt

No Yes

Clear

ADJUSTABLE HERBST - D8410056G19 Catalog Number : 0056G

Device Description : ORAL SLEEP APNEA APPLIANE

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

EZ-Align - D84100911Z Catalog Number : 0091

Device Description : Clear Sequential Aligner System

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

EZ-Align - D8410091L1D Catalog Number : 0091L

Device Description : Sequential Aligner (Lower Tray)

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

EZ-Align - D8410091U1M Catalog Number : 0091U

Device Description : Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray

Device Class : 2

Duns Number: 006335558

Premarket Exempt : Yes

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Dorsal Appliance - D84101101R Catalog Number : 0110

Device Description : Dorsal oral sleep apnea device (Anti Snoring)

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

LISA APPLIANCE - D84101511W Catalog Number :

Device Description : LISA ORAL SLEEP APNEA APPLIANCE

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

EMA APPLIANCE - D84104841 Catalog Number :

Device Description : EMA ORAL SLEEP APNEA APPLIANCE

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

TAP 1 & 3 - D84104911 Catalog Number :

Device Description : TAP ORAL SLEEP APNEA DEVICE

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

TAP ELITE AND DREAM - D8410491E1A Catalog Number :

Device Description : TAP ORAL SLEEP APNEA APPLIANCE ELITE AND DREAM

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

CLEARVIZ - D8412188X1Y Catalog Number :

Device Description : CLEAR ORTHODONTIC PLASTIC/CERAMIC BRACKETS

Device Class : 2

Duns Number: 006335558

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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