Question 1

What types of devices does KaVo Dental GmbH manufacture?

Accepted Answer

KaVo Dental GmbH manufactures ultrasonic dental scaling and debridement systems, dental power tool handpieces (both line-powered and pneumatic), dental delivery systems, dental surgical power tool motors (electric), dental caries detectors using optical induced fluorescence, dental abrasive air jet system handpieces, and dentifrice products. This is based solely on the device categories and examples provided in the source data, which list these as the core product types without specifying quantities or market reach.

Question 2

Where is KaVo Dental GmbH based?

Accepted Answer

KaVo Dental GmbH is based in Germany, as indicated by the country code DE in the device data. This location is explicitly stated in the SUMMARY section and confirmed by the COUNTRY field, with no additional details about facilities, headquarters, or operational sites provided or inferred.

Question 3

In which regulatory registries are KaVo Dental GmbH's devices listed?

Accepted Answer

KaVo Dental GmbH's devices are listed in the Eudamed and FDA UDI registries, as directly stated in the LISTED IN field and reiterated in the SUMMARY. These are the only two registries mentioned in the source data, and no others are referenced or implied.

Question 4

How are KaVo Dental GmbH's devices classified under regulatory frameworks?

Accepted Answer

KaVo Dental GmbH's devices are classified as Class I, Class II, and Class IIa, as explicitly stated in the DEVICE CLASSES field and repeated in the SUMMARY. This classification reflects the risk-based categorization applied to individual devices, not the company itself, and no further breakdown by device type is provided in the source.

Device	Model / Reference	Registries	Class	Status
SONICflex micro Tip No. 28	0.571.6741	FDA UDI	Class II	Active
SONICflex clean Tip No. 48	0.571.0401	FDA UDI	Class II	Active
SONICflex endo Tip No. 69	1.000.5827	FDA UDI	Class II	Active
SONICflex 2003 L	1.000.4243	FDA UDI	Class II	Active
ELECTROmatic TMC-S	1.012.8549	FDA UDI	Class I	Active
INTRA Kopf L62	1.008.1830	FDA UDI	Class I	Active
CORONAflex 2005	0.579.1000	FDA UDI	Class I	Active
EXPERTtorque E679 L	1.006.9200	FDA UDI	Class I	Active
EXPERTmatic E15 L	1.007.5530	FDA UDI	Class I	Active
SURGmatic Head S201 XL Pro	1.013.8662	FDA UDI	Class I	Active
Tube Set S600	1.009.8757	FDA UDI	Class I	Unknown
SONICflex endo Tip No. 66 (A)	1.006.1992	FDA UDI	Class II	Active
PROPHYflex 3 2018 black	1.000.4672	FDA UDI	Class I	Active
Elements 8:1	1.011.6786	FDA UDI	Class I	Active
ELECTROmatic PM-L	1.012.8542	FDA UDI	Class I	Active
SONICflex seal Tip No. 45	1.000.2568	FDA UDI	Class II	Active
Arcus	0.622.5000	FDA UDI	Class I	Active
SONICflex retro Tipset	0.571.0381	FDA UDI	Class II	Active
SURGmatic S11 L	1.009.1010	EUDAMEDFDA UDI	Class I	Active
SONICflex prep gold Tip No. 49	0.571.7212	FDA UDI	Class II	Active
SONICflex prep ceram Tip No. 52	0.571.7272	FDA UDI	Class II	Active
PROPHYflex Perio Powder 20gr.	1.009.5764	FDA UDI	Class I	Active
EXPERTmatic E25 L	1.007.5550	FDA UDI	Class I	Active
ELECTROmatic C-S	1.012.8539	FDA UDI	Class I	Active
EXPERTtorque Mini LUX E677 LM	1.006.3800	FDA UDI	Class I	Active
SONICflex cari-ex 1.4 No. 72	1.000.7363	FDA UDI	Class II	Active
SONICflex micro Tip No. 31 (A)	1.006.1971	FDA UDI	Class II	Active
SONICflex seal Tip No. 45 (A)	1.007.1503	FDA UDI	Class II	Active
SONICflex rootplaner Tipset	0.571.0301	FDA UDI	Class II	Active
SonicFill Handpiece 34920	1.007.2000	FDA UDI	Class II	Active
SONICflex endo Tip No. 68 (A)	1.006.1996	FDA UDI	Class II	Active
SONICflex 2008 L (Set)	1.007.1606	FDA UDI	Class II	Active
EXPERTtorque Mini LUX E677 LN	1.006.0100	FDA UDI	Class I	Active
SONICflex retro Tip No. 55	0.571.7342	FDA UDI	Class II	Active
SONICflex retro Tip No. 21	0.571.5561	FDA UDI	Class II	Active
RONDOflex powder 27m (1000g)	1.000.5957	FDA UDI	Class II	Active
SMARTtorque Mini S605 C	1.008.1645	FDA UDI	Class I	Active
SONICflex clean Brush No. 2	0.571.0412	FDA UDI	Class II	Active
MASTERtorque Mini LUX M4500 L	1.007.1700	FDA UDI	Class I	Active
SONICflex micro Tip No. 33 (A)	1.006.1975	FDA UDI	Class II	Active
ELECTROtorque plus	1.001.8748	FDA UDI	Class I	Active
SONICflex retro, left	0.571.5601	FDA UDI	Class II	Active
COMFORTtronic 4894	1.005.0169	FDA UDI	Class I	Active
INTRA Endo Kopf L53	1.008.1826	FDA UDI	Class I	Active
SMARTmatic S80 K	1.011.6771	FDA UDI	Class I	Active
EXPERTmatic E61 C	1.008.4999	FDA UDI	Class I	Active
SONICflex endo Tip No. 68	1.000.5823	FDA UDI	Class II	Active
SONICflex retro Tip No. 20 (A)	1.006.2037	FDA UDI	Class II	Active
KaVo PROPHYpearls peach	1.010.1829	FDA UDI	Class I	Active
KaVo PROPHYpearls mint	1.010.1828	FDA UDI	Class I	Active

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