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

Agent, Tooth Bonding, Resin (KLE) (4) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (3) Material, Tooth Shade, Resin (EBF) (1) Powder, Porcelain (EIH) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

TRANSBOND LOLLYPOPS ETCH/PRIMER-20 PACK - D8281330604 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 20

TRANSBOND LOLLYPOPS ETCH/PRIMER-100 PACK - D8281330605 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 100

TRANSBOND SYRINGE - D8281330606 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 4

TRANSBOND PRIMER - D82813306070 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

TRANSBOND MIP PRIMER - D82813306080 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

TRANSBOND LR - D8281330610 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 25

RELY A BOND PASTE 3.5 GM SYRINGE - D82813306120 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

LCR RETAINER PASTE TIPS - D8281330621 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 11

ULTRA BAND LOK BLUE - D8281330700 Catalog Number :

Device Class :

Duns Number: 113352686

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 6

PORCELAIN ETCH AND BARRIER GEL - D82813309000 Catalog Number :

Device Class : 2

Duns Number: 113352686

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

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