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 rootplaner Tip No. 24 (A)	1.006.1957	FDA UDI	Class II	Active
QUATTROcare PLUS 2124 A	1.008.3805	FDA UDI	Class I	Active
INTRA Kopf L68	1.008.1833	FDA UDI	Class I	Active
SONICflex retro Tip No. 57 (A)	1.006.2041	FDA UDI	Class II	Active
ELECTROmatic TMM-S	1.012.8547	FDA UDI	Class I	Active
SONICflex micro Tip No. 31	0.571.6801	FDA UDI	Class II	Active
SONICflex cari-ex 1.4 No. 72 (A)	1.006.2004	FDA UDI	Class II	Active
INTRA Surgery Handpiece 3630 N	0.534.5670	FDA UDI	Class I	Active
MASTERtorque Mini Kids Edition (en)	1.011.2330	FDA UDI	Class I	Active
SONICflex prep ceram Tip No. 51	0.571.7262	FDA UDI	Class II	Active
PROPHYflex 4 S Flamingo	3.004.5950	FDA UDI	Class I	Active
SONICflex 2003 L (Set)	1.000.8333	FDA UDI	Class II	Active
SONICflex endo Tip No. 67	1.000.5822	FDA UDI	Class II	Active
SONICflex scaler Tipset	1.000.4983	FDA UDI	Class II	Active
SMARTtorque S619 C	1.008.1642	FDA UDI	Class I	Active
DIAGNOdent pen 2190 US	1.002.7000	FDA UDI	Class II	Active
DIAGNOdent Paro Tip Saphir without scale	1.004.0370	FDA UDI	Class II	Active
MASTERmatic LUX M20 L	1.009.3620	FDA UDI	Class I	Active
MASTERtorque LUX M8900 L	1.008.7800	FDA UDI	Class I	Active
CAD-CAM mesial gebogen No. 34	1.002.1984	FDA UDI	Class II	Active
SONICflex paro Tip No. 60 (A)	1.006.1934	FDA UDI	Class II	Active
INTRA Surgery Handpiece 3610 N2	0.524.5610	FDA UDI	Class I	Active
SONICflex bevel Tip No. 58 (A)	1.006.1988	FDA UDI	Class II	Active
SONICflex prep gold Tipset (A)	1.006.2028	FDA UDI	Class II	Active
ELECTROmatic TM-L	1.012.8546	FDA UDI	Class I	Active
SONICflex cari-ex 1.2 No. 43 (A)	1.006.1981	FDA UDI	Class II	Active
SONICflex prep gold Tipset	0.571.0321	FDA UDI	Class II	Active
SONICflex cari-ex TC Tipset	1.000.7379	FDA UDI	Class II	Active
RONDOflex powder 27m (75g)	1.000.5955	FDA UDI	Class II	Active
SONICflex micro Tip No. 32	0.571.6831	FDA UDI	Class II	Active
COMFORTdrive 200XDR	1.007.3570	FDA UDI	Class I	Active
SMARTtorque Mini LUX S615 L	1.008.1643	FDA UDI	Class I	Active
SONICflex cari-ex 0.8 No. 42	1.000.7105	FDA UDI	Class II	Active
INTRAmatic 80 E	1.004.6401	FDA UDI	Class I	Active
INTRAflex LUX2 2307 LN	0.535.6190	FDA UDI	Class I	Active
SONICflex clean Brushset (A)	1.006.2026	FDA UDI	Class II	Active
PROPHYflex powder berry	1.007.0015	FDA UDI	Class I	Active
GENTLEpower LUX 10 LP	1.001.5660	FDA UDI	Class I	Active
EXPERTtorque E675 LMW	1.006.0800	FDA UDI	Class I	Active
SONICflex retro Tip No. 17 (A)	1.006.2035	FDA UDI	Class II	Active
INTRAmatic 10 E	1.003.6977	FDA UDI	Class I	Active
INTRAmatic 31 ES	1.003.1109	FDA UDI	Class I	Active
SONICflex micro Tip No. 30 (A)	1.006.1969	FDA UDI	Class II	Active
SONICflex prep ceram Tip No. 52 A	1.006.1986	FDA UDI	Class II	Active
DIAGNOdent pen 2190	1.002.7000	FDA UDI	Class II	Active
Intra L-Lux 181 L	0.535.5210	FDA UDI	Class I	Active
SONICflex prep CAD-CAM Tipset (A)	1.006.2024	FDA UDI	Class II	Active
INTRAmatic KL 703 LED	1.007.0150	FDA UDI	Class I	Active
SONICflex cari-ex D Tipset (A)	1.006.2025	FDA UDI	Class II	Active
PROPHYflex powder mint	1.007.0017	FDA UDI	Class I	Active

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