HANDPIECE PARTS & REPAIRS, INC.

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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

Handpiece, Air-Powered, Dental (EFB) (8) Controller, Foot, Handpiece And Cord (EBW) (2)

Premarket Exempt

Clear

KINETIC INSTRUMENTS - 00810988030315 Catalog Number : 17-205

Device Description : KINETIC VIPER 3 HANDPIECE - F.O. NSK FITTING

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

HAYES HANDPIECE - 00810988030339 Catalog Number : HAHYGENIE

Device Description : HAYES HYGENIE HYGIENIST HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030346 Catalog Number : MEDI-012PL1

Device Description : MEDIDENTA iCLEAN HANDPIECE MAINTENANCE MACHINE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

CHOICE PRO - 00810988030353 Catalog Number : TDC-012PL1

Device Description : TDC CHOICE PRO HANDPIECE MAINTENANCE SYSTEM

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

CHOICE PRO - 00810988030360 Catalog Number : EJ0008-TDC

Device Description : TDC CHOICE PRO ELECTRIC HANDPIECE SYSTEM

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EBW

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030377 Catalog Number : EJ0008-MEDI

Device Description : MEDILECTRIC ELECTRIC HANDPIECE SYSTEM

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EBW

Prescription Use : Yes

Device Count : 1

BRASSELER USA - 00810988030391 Catalog Number : 5026059U2

Device Description : ASPEN BRIO 440 HIGH SPEED AIR HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030414 Catalog Number : AK-CMPB4H

Device Description : MEDIDENTA AIR KING 4-HOLE PUSH BUTTON (CERAMIC) MINI HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

Medidenta - 00810988030438 Catalog Number : iSPRAY

Device Description : MEDIDENTA iSPRAY Handpiece Cleaner Lubricant

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030445 Catalog Number : TT1200

Device Description : MEDIDENTA TURBO TORQUE 1200 MINI HEAD

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

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