PREMIER DENTAL PRODUCTS COMPANY

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) (9) Tube, Tracheostomy (W/Wo Connector) (BTO) (1)

Premarket Exempt

No Yes

Clear

Neo Tray - 00348783000436 Catalog Number :

Device Description : Neo Tray™ Posterior – Box of 48

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000443 Catalog Number :

Device Description : Neo Tray™ Sideless Posterior – Box of 48

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000450 Catalog Number :

Device Description : Neo Tray™ Quadrant – Box of 40

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000467 Catalog Number :

Device Description : Neo Tray™ Anterior – Box of 30

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000474 Catalog Number :

Device Description : Neo Tray™ Full Arch – Box of 30

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000481 Catalog Number :

Device Description : Neo Tray™ Introductory Kit – Box of 45

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000498 Catalog Number :

Device Description : Neo Tray™ Extended Quadrant – Box of 35

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000504 Catalog Number :

Device Description : Neo Tray™ Wide Posterior – Box of 48

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Neo Tray - 00348783000511 Catalog Number :

Device Description : Neo Tray-one each

Device Class : 1

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

Premier - 00856402006016 Catalog Number :

Device Description : TT Air-Lon® Sz 4

Device Class : 2

Duns Number: 014789663

Premarket Exempt : Yes

Product Code : BTO

Prescription Use : Yes

Device Count : 1

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