Manufacturer

Wh

Austria, ItalyLegal entities : W & H Dentalwerk Bürmoos GmbH, W&H Sterilization Srl

Markets : Austria · France · Ireland · Italy · Malta · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 9 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 17 · Sweden 1

Website RA@wh.com

12 categories, 76 models including 74 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Tartar ablators	Z12119001	Air Scaler Tips Prophy&Paro3 refs C-NW2 refs PB-393/42 PB-3 LED S93/42 PB-3 S93/42 25 others PB-5 L2 refs93/42 PB-5 L S2 refs93/42 PB-51093/42 PB-52093/42 PB-53093/42 PL-40 H2 refs SF1LM3 refs Spitze 1E mit Gabelschluessel93/42 Spitze 1I mit Spitzenwechsler93/42 Spitze 1P mit Spitzenwechsler2 refs93/42 Spitze 1PS mit Spitzenwechsler2 refs93/42 Spitze 1U mit Spitzenwechsler2 refs93/42 Spitze 1US mit Spitzenwechsler2 refs93/42 Spitze 2U mit Spitzenwechsler93/42 Spitze 2US mit Spitzenwechsler93/42 Spitze 3E mit Gabelschluessel93/42 Spitze 3Pl mit Spitzenwechsler93/42 Spitze 3Pr mit Spitzenwechsler93/42 Spitze 3U mit Spitzenwechsler2 refs93/42 Spitze 3US mit Spitzenwechsler2 refs93/42 Spitze 6E mit Spitzenwechsler93/42 Spitzenset: 1U, 3U, 1P93/42 Spitzenset: 3x 1I93/42 VP-393/42 VP-52 refs93/42	IIa MDR, 93/42	EUDAMED record Report an error
Various dental stomatology instruments - other	Z12119099	B13 refs EM-193 refs S-103 refs S-12 3006100093/42 S-8 O3 refs 9 others S-N23 refs S-NW3 refs SA-3202 refs93/42 SA-403 refs SA-430 M3 refs SI-10103 refs WS-902 refs Implantmed SI-92393/42 (no longer marketed) S-1193/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Instruments for dental treatment units - hardware accessories	Z12110180	AM-05 MW RM3 refs EM-11 L93/42 EM-12 L93/42 HE-433 refs HP-44 M 101144033 refs 6 others OS30 RA-243 refs RC-90 BC3 refs VE-1093/42 VE-1193/42 WG-67 A3 refs	IIa MDR, 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	M-MH402 refs M-PH350 M-PM100 M-SD0903 refs M-UK10103 refs 3 others MP13 refs MP1-S3 refs S-103 refs	IIa MDR	EUDAMED record Report an error
Dental cleaning/washing handpiece equipments	Z12119006	Assistina 301 plus 000301353 refs MB-3013 refs MB-302 303100003 refs MCA-ISO-BC3 refs MD-200 SERVICE-ÖL F1 200mL W&H Service Oil F13 refs 1 other MD-4003 refs	I MDR	EUDAMED record Report an error
Cleaning and decontamination systems for general and multidisciplinary surgery instruments	Z12011306	BEPRO SOAKING BATH 13730	I MDR	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	THED RID-300TT 667973 refs	IIb MDR	EUDAMED record Report an error
Equipment for digital endoral radiology	Z1103040102	seethroughARM XRI-100 422973 refs	IIb MDR	EUDAMED record Report an error
Equipment for extraoral dental radiology, digital	Z1103030102	seethroughFLEX XRE-200 610193 refs	IIb MDR	EUDAMED record Report an error
Instruments for extraoral dental radiology - medical device software	Z11030392	seethrough studio DID-200 60883	IIa MDR	EUDAMED record Report an error
Small load autoclaves with a chamber smaller than 1 standard sterilisation unit	Z12011305	21E 386713 refs	IIb MDR	EUDAMED record Report an error
Ultrasonic cleaning equipment	Z12011302	U-Son RIW-203 367492 refs	I MDR	EUDAMED record Report an error

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