FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Address:2928 Metro Street,Denton,TX,76207,US

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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) (5) Device, Jaw Repositioning (LQZ) (1) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (1) Material, Impression Tray, Resin (EBH) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1) Wire, Orthodontic (DZC) (1) Headgear, Extraoral, Orthodontic (DZB) (1)

Premarket Exempt

Yes No

Clear

PORCELAIN CONDITIONER - D82813309010 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Triad Gel - D82813390010 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Indirect Bonding Adhesive - D82815308650 Catalog Number :

Device Class : 1

Duns Number: 113352686

Premarket Exempt : No

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Pedo Reverse Pull Face Mask - D8282200180 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Vivos DNA - D82852000130 Catalog Number :

Device Class : 1

Duns Number: 113352686

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Vivos mRNA - D82852000140 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

EMA - D82852000280 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Vivos mmRNA - D82852000920 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : LRK, LQZ

Prescription Use : Yes

Device Count : 1

Tap III Anti-Snoring Device - D82852001070 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Dream TAP - D82852001090 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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