Dentsply Professional

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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

Dental barriers and sleeves (PEM) (10) HANDPIECE, AIR-POWERED, DENTAL (EFB) (10)

Premarket Exempt

No Yes

Clear

Disposa-Shield® - D003A880051 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Low Speed, Contra-Angle Handpiece. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A880061 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Low Speed, Long Handpiece. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A880071 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Universal Air/Water Syringe. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A880081 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Light Handle (T-Bar). Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EFB

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A8800951 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Dental Hose. Box of 175

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 175

Disposa-Shield® - D003A8801051 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Universal Chair Back/X-Ray Head. Box of 150

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 150

Disposa-Shield® - D003A8801151 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier Multi-Purpose Use Sheets. Box of 1200

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EFB

Prescription Use : Yes

Device Count : 1200

Disposa-Shield® - D003A880131 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Use With: Standard Syringe Type Delivery Disposa-Shield® Disposable Barrier For Use With: Standard Syringe Type Delivery Systems. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A880141 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Tray Cover 10.5 x 14.5. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : PEM, EFB

Prescription Use : Yes

Device Count : 500

Disposa-Shield® - D003A880151 Catalog Number :

Device Description : Disposa-Shield® Disposable Barrier For Tray Cover 12 x 17. Box of 500

Device Class :

Duns Number: 144140845

Premarket Exempt : No

Product Code : EFB, PEM

Prescription Use : Yes

Device Count : 500

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