PREMIER DENTAL PRODUCTS COMPANY

Address:1710 ROMANO DR.,PLYMOUTH MEETING,PA,19462,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

Tray, Impression, Preformed (EHY) (7) Tube, Tracheostomy (W/Wo Connector) (BTO) (2) Scaler, Ultrasonic (ELC) (1)

Premarket Exempt

Yes No

Clear

Premier - 00856402006337 Catalog Number :

Device Description : Decan Stopper Size 8 Closure Full

Device Class : 2

Duns Number: 014789663

Premarket Exempt : No

Product Code : BTO

Prescription Use : Yes

Device Count : 1

Premier - 00856402006344 Catalog Number :

Device Description : Decan Stopper Size 9 Closure Full

Device Class : 2

Duns Number: 014789663

Premarket Exempt : No

Product Code : BTO

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000011 Catalog Number :

Device Description : ACCU BITE Tray Posterior – Box of 50

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000014 Catalog Number :

Device Description : ACCU BITE Tray Half Arch – Box of 40

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000016 Catalog Number :

Device Description : ACCU BITE Tray Anterior – Box of 30

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000018 Catalog Number :

Device Description : ACCU BITE Tray Full Arch – Box of 30

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000023 Catalog Number :

Device Description : ACCU BITE Tray Ext Half Arch – Box of 40

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000027 Catalog Number :

Device Description : ACCU BITE Tray Wide Posterior – Box of 50

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

ACCU BITE - D691100000031 Catalog Number :

Device Description : ACCU BITE Tray Sideless – Box of 50

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Premier - D6911005300 Catalog Number :

Device Description : Big Easy Insert #10 Universal 25K

Device Class : 2

Duns Number: 014789663

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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