W & H Dentalwerk Bürmoos GmbH

Address:53 IGNAZ-GLASER-STRASSE,BUERMOOS Salzburg,AT

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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) (4) Drill, Bone, Powered (DZI) (3) Handpiece, Rotary Bone Cutting (KMW) (3) Scaler, Ultrasonic (ELC) (3)

Premarket Exempt

Clear

MB-301 Assistina ONE - J021303980011 Catalog Number :

Device Description : Cleaning/Lubrication Unit

Device Class : 1

Duns Number: 300238441

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MB-301 Assistina ONE - J021303980021 Catalog Number :

Device Description : Cleaning/Lubricating Unit

Device Class : 1

Duns Number: 300238441

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

MB-301 Assistina ONE - J021303980031 Catalog Number :

Device Description : Cleaning/Lubricating Unit

Device Class : 1

Duns Number: 300238441

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

Piezomed SA-435 M Module plus - J021304060001 Catalog Number :

Device Description : Piezoelectric Ultrasonic Device

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : DZI, ELC

Prescription Use : Yes

Device Count : 1

Piezomed SA-430 M Module classic - J021304070001 Catalog Number :

Device Description : Piezoelectric Ultrasonic Device

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : DZI, ELC

Prescription Use : Yes

Device Count : 1

Handpiece SA-40 with cable 1.8 m - J021304080001 Catalog Number :

Device Description : Piezomed Accessory

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : DZI, ELC

Prescription Use : Yes

Device Count : 1

S-16 Surgical Handpiece 1:2 - J021304110001 Catalog Number :

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

WI-75 LED G IMPLANTOL.FRIADENT - J021329068101 Catalog Number : 90-6810

Device Description : Surgical Handpiece

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

SI-11 LED G, FRIADENT - J021329068501 Catalog Number : 90-6850

Device Description : Surgical handpiece

Device Class : 2

Duns Number: 300238441

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

TK-98 LM Synea Vision - J02300200001 Catalog Number :

Device Description : Synea Vision Highspeed Handpiece

Device Class : 1

Duns Number: 300238441

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

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