Manufacturer

Sirona Dental Systems

GermanyLegal entities : Sirona Dental Systems GmbH

Markets : Denmark · France · Germany · Italy · Netherlands · Northern Ireland · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 42 · class I, II · latest in 2016 · see on the FDA website

Public contracts won : Germany 2

Website contact@dentsplysirona.com

12 categories, 79 models including 79 on the market, 1 country

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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
Instruments for dental treatment units - hardware accessories	Z12110180	Air Motor B93/42 Air Motor M93/42 Endo 6:193/42 Energo EVA 04 L3 refs Jet Essence B93/42 35 others Jet Essence M93/42 Midwest Phoenix® PK3 refs Midwest® E Plus 1:193/42 Midwest® E Plus 1:593/42 SiroNiTi Air Plus Apex93/42 SiroNiTi Apex93/42 T1 Line C 1,6 L93/42 T1 Line C 200 L93/42 T1 Line C 40 L93/42 T1 Line C 6 L93/42 T1 Line Endo 6 L93/42 T1 Line EVA 04 L93/42 T1 Line EVA 11 L93/42 T1 Line H 40 L Straight handpiece93/42 T1 Line Prophy93/42 T2 Line A 200 L93/42 T2 Line A 200 L Top Dent93/42 T2 Line A 40 L93/42 T2 Line A 40 L Top Dent93/42 T2 Line A 6 L93/42 T2 Line AH 40 L Straight handpiece93/42 T2 S-Line AS 200 L93/42 T2 S-Line AS 40 L93/42 T2 S-Line AS 6 L93/42 T3 Line E 20093/42 T3 Line E 4093/42 T3 Line E 693/42 T3 Line EH 40 Straight handpiece93/42 T3 Line EVA 1193/42 T3 S-Line ES 20093/42 T3 S-Line ES 4093/42 T3 S-Line ES 693/42 T4 Line B 4093/42 T4 Line BH 40 Straight handpiece93/42 VDW 6:193/42	IIa MDR, 93/42	EUDAMED record Report an error
Various digital bioimaging management instruments - medical device software	Z11069092	CEREC SW 5.3 Full version dig., Primary93/42 CEREC SW 5.3 Full version, Primary93/42 CEREC SW 5.3 license93/42 CEREC SW 5.3 License Key Upgrade93/42 CEREC SW 5.3 license upgrade digital93/42 5 others CEREC SW 5.3 Workstation dig., Secondary93/42 CEREC SW 5.3 Workstation, Secondary93/42 CEREC SW V5.393/42 Connect SW V5.293/42 OraCheck 5.0 Software93/42	I 93/42	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	Axeos93/42 Axeos (individ.)93/42 Axeos (ww)93/42 Orthophos E93/42 Orthophos E Ceph93/42 4 others Orthophos E individ.93/42 Orthophos E Pan93/42 ORTHOPHOS S 2D3 refs Primevision 3D2 refs	IIb MDR, 93/42	EUDAMED record Report an error
Equipment for conventional endoral radiology	Z1103040101	Ceiling Version HELIODENT Plus93/42 HD Plus complete w/o support arm (wall module, round)93/42 HD PLUS complete w/o support arm (wall module, square)93/42 HD Plus w/o support arm93/42 HD Plus Wall version (round)93/42 2 others HD PLUS Wall version (square)93/42 HELIODENT Plus, Unit model93/42	IIb 93/42	EUDAMED record Report an error
Dental treatment units	Z12110101	lntego2 refs Sinius3 refs Treatment Center Axano2 refs X-Smart Pro2 refs	IIa MDR	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	DAC Universal93/42 DAC Universal D93/42	IIb 93/42	EUDAMED record Report an error
Instruments for dental treatment units - other	Z12110199	Midwest Plus Spray 250ml 6 pieces3 refs Midwest Power Lux Electric Motor System2 refs	I, IIa MDR	EUDAMED record Report an error
Diode surgical laser	Z12011016	SiroLaser Advance Plus Basic Device3 refs	IIb MDR	EUDAMED record Report an error
Fixed scialytic lamps	Z12010701	Ceiling Model LEDview Plus3 refs	I MDR	EUDAMED record Report an error
Laser surgery instruments - consumables	Z12011085	EasyTip 200 Pack 253 refs	IIa MDR	EUDAMED record Report an error
Multiformat cameras	Z11039003	SiroCam AF3 refs	I MDR	EUDAMED record Report an error
Various digital bioimaging management instruments - software accessories	Z11069082	Sidexis 4 V4.4	IIa MDR	EUDAMED record Report an error

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