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) (6) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (4)

Premarket Exempt

Clear

CHOICE PRO - 00810988030568 Catalog Number : CP100PL

Device Description : TDC CHOICE PRO PUSH LATCH HEAD

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

CHOICE PRO - 00810988030575 Catalog Number : CP100S

Device Description : TDC CHOICE PRO CONTRA ANGLE SHEATH

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

CHOICE PRO - 00810988030582 Catalog Number : CP20K

Device Description : TDC CHOICE PRO 20K E-TYPE MOTOR

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

CHOICE PRO - 00810988030605 Catalog Number : CP300P

Device Description : TDC CHOICE PRO PEDO 4-HOLE HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030629 Catalog Number : PM-MAMH

Device Description : PROPHY MAGIC MAGIC AIR 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 - 00810988030636 Catalog Number : PM-MASH

Device Description : PROPHY MAGIC MAGIC AIR 4-HOLE PUSH BUTTON (CERAMIC) STANDARD HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

QUALITY PLUS - 00810988030643 Catalog Number : SM01

Device Description : QDSC QUALITY PLUS SM01 4-HOLE MINI SCREW TYPE HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030650 Catalog Number : PROPHYPRO

Device Description : MEDIDENTA HYGIENIST HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030667 Catalog Number : AK-CPB2H

Device Description : MEDIDENTA AIR KING 2-HOLE PUSH BUTTON (CERAMIC) STANDARD HANDPIECE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MEDIDENTA - 00810988030704 Catalog Number : MW-NC

Device Description : MIDWEST COMPATIBLE STRAIGHT NOSE CONE

Device Class : 1

Duns Number: 079723355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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