Plastcare USA

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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

Material, Impression Tray, Resin (EBH) (3) Non-Surgical Isolation Gown (OEA) (2) Indicator, Physical/Chemical Sterilization Process (JOJ) (1) Mouthpiece, Saliva Ejector (DYN) (1) Syringe, Irrigating (Dental) (EIB) (1)

Premarket Exempt

No Yes

Clear

Plastcare - D915RIT73121 Catalog Number :

Device Description : Dental Impression Bite Tray Anterior (Purple)

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 35

Plastcare - D915RIT73131 Catalog Number :

Device Description : Dental Impression Bite Tray Quadrant (Yellow)

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 35

Plastcare - D915RIT73151 Catalog Number :

Device Description : Dental Impression Bite Tray Sideless (White)

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 50

Plastcare - D915RIT75141 Catalog Number :

Device Description : (7 1/2" x 14") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RITG30B1 Catalog Number :

Device Description : Isolation Gown with Knit Cuffs - Blue

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Plastcare - D915RITG30P1 Catalog Number :

Device Description : Isolation Gown with Knit Cuffs - Pink

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Plastcare - D915S12CC1 Catalog Number :

Device Description : Utility syringe curved 12cc

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EIB

Prescription Use : No

Device Count : 50

Plastcare - D915WHW1 Catalog Number :

Device Description : Saliva Ejector White with White Tip

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

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