Manufacturer registered with FDA
KaVo Dental GmbH
Biberach, Germany. Lists 20 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 434
- 510(k) clearances
- 22006–2021
- Markets registered in
- 16550 registrations outside the US
- Establishments
- 2Germany
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name KaVo Dental GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | KaVo Dental GmbH | 2 clearances | 2006–2021 | Below |
| South Korea | MFDS | Manufacturer | KaVo Dental GmbHKAVO Dental GmbH · KaVoDental GmbH · +1 | 135 | 2003–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | KAVO DENTAL GMBH | 133 | 1999–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | KaVo Dental GmbH | 101 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KAVO DENTAL GMBH | 35 | 2005–2026 | Pure Global AI |
| China | NMPA | Registration holder | 卡瓦有限责任公司KaVo Dental GmbH | 27 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | KaVo Dental GmbH | 26 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | KaVo Dental GmbH | 21 | — | Pure Global AI |
| Australia | TGA | Manufacturer | KaVo Dental GmbH | 20 | 2016–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | KaVo Dental GmbH | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KAVO DENTAL GMBH | 8 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | KaVo Dental GmbHKAVO Dental GmbH · Kavo Dental GmbH | 7 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | KaVo Dental GmbH | 6 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KAVO DENTAL GMBH | 5 | 2025–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | KAVO DENTAL GMBH | 4 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | KAVO DENTAL GMBH | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What KaVo Dental GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | 0.535.5200 - INTRA-L-MOTOR 181 H0.535.5210 - INTRA L-LUX 181 L0.535.5250 - INTRAmatic 181 M0.535.5260 - INTRA 181 K 20 000 R.P.M.0.535.6180 - INTRAflex LUX2 2320 LN0.535.6190 - INTRAflex LUX2 2307 LN0.535.6200 - INTRAflex LUX2 2329 LN0.535.6210 - INTRAflex LUX2 2325 LN0.535.6220 - INTRAflex LUX2 2313 LN0.553820 - COMPACTtorque 636 CP 95 more100.4672 - PROPHYflex 3 2018 black101.5660 - GENTLEpower LUX 10 LP101.7452 - GENTLEpower LUX 7 LP101.7453 - GENTLEpower LUX 20 LP101.7454 - GENTLEpower LUX 29 LP101.7522 - POWERtorque 646 B101.8776 - INTRA LUX Motor KL 701102342 - PROPHYpearls103.1107 - INTRAmatic 20 E103.1108 - INTRAmatic 14 E103.1109 - INTRAmatic 31 ES103.2278 - PROPHYwiz 181 P103.6976 - INTRAmatic 31 E103.6977 - INTRAmatic 10 E103.9882 - Trio-Pack 181P/181P/181P104.4456 - INTRA Kopf L80104.4503 - INTRAmatic 19 ES104.5380 - INTRAmatic 23 ES104.6401 - INTRAmatic 80 E104.6403 - INTRAmatic 19 E105.5000 - COMFORTdrive System105169 - COMFORTtronic 4894106.6400 - EXPERTtorque E675 L106.9200 - EXPERTtorque E679 L106.9926 - PROPHYflex 3 2018 violet106.9928 - PROPHYflex 3 2018 green106780 - GENTLEsilence LUX gold 8000 BR106800 - EXPERTtorque E675 LMW107.1700 - GENTLEmini LUX 4500BR107.1700 - MASTERtorque Mini LUX M4500 L107.2400 - GENTLEsilence LUX 6500 BR107.3570 - COMFORTdrive 200XDR107.3580 - GENTLEpower LUX 25 LPR107.3600 - EXPERTtorque Mini LUX E677 L107.5530 - EXPERTmatic E15 L107.5531 - EXPERTmatic E15 C107.5540 - EXPERTmatic E20 L107.5541 - EXPERTmatic E20 C107.5550 - EXPERTmatic E25 L107.5551 - EXPERTmatic E25 C107.5560 - EXPERTmatic E10 C107.7100 - MASTERtorque LUX M9000 L COLOR107014 - PROPHYflex powder orange107015 - PROPHYflex powder berry107016 - PROPHYflex powder cherry107017 - PROPHYflex powder mint107641 - PROPHYflex powder mailing108.1641 - SMARTtorque LUX S619 L108.1642 - SMARTtorque S619 C108.1643 - SMARTtorque Mini LUX S615 L108.1644 - SMARTtorque S609 C108.1645 - SMARTtorque Mini S605 C108.1822 - INTRA Endo Kopf L3108.1823 - INTRA Endo Kopf L3 Y108.1824 - INTRA Prophy Kopf L31108.1825 - INTRA Mini Kopf L52108.1826 - INTRA Endo Kopf L53108.1828 - INTRA EVA Kopf L61 G108.1829 - INTRA EVA Kopf L61 R108.1830 - INTRA Kopf L62108.1831 - INTRA Kopf L66 B108.1832 - INTRA Kopf L67108.1833 - INTRA Kopf L68108.1834 - INTRA Kopf L68 B108.1835 - INTRA Micro Kopf L22108.4998 - EXPERTmatic E31 C108.4999 - EXPERTmatic E61 C108.7800 - MASTERtorque LUX M8900 L109.3732 - KaVo PROPHYflex Perio Powder (4x Fl.)110.1798 - KaVo PROPHYpearls neutral (4x 1 Fl.)110.1826 - KaVo PROPHYpearls neutral110.1828 - KaVo PROPHYpearls mint110.1829 - KaVo PROPHYpearls peach110.1830 - KaVo PROPHYpearls orange110.1831 - KaVo PROPHYpearls black currant110287 - Refill PROPHYflex perio tip111.2330 - MASTERtorque Mini Kids-Edition en111.9400 - Adapter perio tip111.9403 - PROPHYflex 4 Perio Kit112.1000 - Power cannula113.4400 - PROPHYpearls Selection200922 - PROPHYflex perio tip300.4808 - SURGtorque LUX S459 L300.5063 - SURGtorque S459 C301.2200 - MASTERtorque Mini LUX M8700 LY301.3400 - MASTERtorque Mini LUX M8700 LK301000 - MASTERtorque Mini LUX M8700 L301600 - MASTERtorque Mini LUX M8700 LS302.8000 - PROPHYflex 4 Wave302.8200 - PROPHYflex 4 Lime302.8800 - PROPHYflex 4 Flamingo303.1138 - Cannula304.5900 - PROPHYflex 4 S Wave304.5930 - PROPHYflex 4 S Lime304.5950 - PROPHYflex 4 S Flamingo | 2012 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | COMFORTdrive 200 XD - 100.5500ELECTROmatic C - L - 112.8540ELECTROmatic C - S - 112.8539ELECTROmatic M - L - 112.8538ELECTROmatic M - S - 112.8537ELECTROmatic M/C - 111.1800ELECTROmatic PC - L - 112.8544ELECTROmatic PC - S - 112.8543ELECTROmatic PM - L - 112.8542ELECTROmatic PM - S - 112.8541 39 moreELECTROmatic PM/PC - 111.1900ELECTROmatic T2M - S - 113311ELECTROmatic TM - 111.2100ELECTROmatic TM - L - 112.8546ELECTROmatic TM - S - 112.8545ELECTROmatic TMC - L - 112.8550ELECTROmatic TMC - S - 112.8549ELECTROmatic TMM - L - 112.8548ELECTROmatic TMM - S - 112.8547ELECTROmatic TMM/TMC - 111.2600elements e-motion - 113.3300Handpiece tubing 1.370 A-dec - 114.5690handpiece tubing 1.830 A-dec - 114.7770INTRA LUX Motor KL 703 LED - 107150Orion Dual Motor Control - 111.7169101.8748 - ELECTROtorque plus102.5015 - ELECTROtorque plus (Set)103.3490 - ELECTROtorque TLC 4893103.5622 - INTRAmatic LUX 702 KL103.5840 - ELECTROtorque TLC 4893 (Set)107150 - INTRAmatic KL 703 LED108.3500 - EXPERTsurg LUX108.8000 - INTRA LUX S600 LED109.1005 - SURGmatic S11 C109.1010 - SURGmatic S11 L109.1100 - SURGmatic S201 C109.1200 - MASTERsurg LUX109.8757 - Tube Set S600109470 - SURGmatic S201 L110.2332 - SURGmatic S201 XL110.2333 - SURGmatic S201 XC110.8042 - Demo Unit EXPERTsurg LUX110.9726 - Demo Unit MASTERsurg LUX111.4900 - SM5113.7540 - SURGmatic S201 L Pro113.7541 - SURGmatic S201 XL Pro113.8648 - SURGmatic Head S201 L Pro113.8662 - SURGmatic Head S201 XL Pro115960 - INTRA LUX KL703 LED Planmeca | 2012 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | 0.574500 - DIAGNOdent 2095104.1640 - DIAGNOdent 2095 perio tip111.1213 - DIAGNOcam Vision Full HD111.4444 - DEXIS CariVu 3-in-1 by KaVo113.1500 - DIAGNOcam Vision Full HD113.1700 - DEXIS CariVu 3-in-1 by KaVo U115.3700 - DIAGNOcam Vision Full HD | 2012 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | 102.7000 - DIAGNOdent pen 2190102.8568 - DIAGNOdent Paro Tip Saphir with scale104.8400 - DIAGNOdent Display 2191104370 - DIAGNOdent Paro Tip Saphir without scale110.1010 - DEXIS CariVu111.1213 - DIAGNOcam Vision Full HD111.4444 - DEXIS CariVu 3-in-1 by KaVo113.1500 - DIAGNOcam Vision Full HD113.1700 - DEXIS CariVu 3-in-1 by KaVo U115.3700 - DIAGNOcam Vision Full HD | 2012 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | 0.411.9650 - KaVo Spray AMERICA 21130.411.9660 - KaVo Spray AMERICA 2113 (Set)105.3844 - QUATTROcare plus Spray AMERICA 2141105.4524 - QUATTROcare plus Spray AMERICA 2141 (Set)107.2000 - SonicFill Handpiece 34920108.3805 - QUATTROcare PLUS 2124 A108525 - SonicFill Handpiece Lubrication Spray | 2012 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | elements 8:1 - 111.6786SMARTmatic ENDO S321 - 111.6790SMARTmatic ENDO S81 - 111.6780SMARTmatic PROPHY S19 - 111.6740SMARTmatic PROPHY S19 K - 111.6741SMARTmatic PROPHY S31 - 111.6760SMARTmatic PROPHY S31 K - 111.6761SMARTmatic PROPHY S33 - 111.6800SMARTmatic S10 - 111.6730SMARTmatic S10 K - 111.6731 13 moreSMARTmatic S10 S - 111.6732SMARTmatic S20 - 111.6750SMARTmatic S20 K - 111.6751SMARTmatic S20 S - 111.6752SMARTmatic S53 - 111.6810SMARTmatic S80 K - 111.6771109.3570 - MASTERmatic M10 L109.3580 - MASTERmatic M29 L109.3610 - MASTERmatic M07 L109.3620 - MASTERmatic M20 L109.3630 - MASTERmatic M25 L109.3640 - MASTERmatic M05 L114280 - MASTERmatic LUX M45 L | 2015 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | 100.4672 - PROPHYflex 3 2018 black102342 - PROPHYpearls106.9926 - PROPHYflex 3 2018 violet106.9928 - PROPHYflex 3 2018 green107014 - PROPHYflex powder orange107015 - PROPHYflex powder berry107016 - PROPHYflex powder cherry107017 - PROPHYflex powder mint107641 - PROPHYflex powder mailing109.3732 - KaVo PROPHYflex Perio Powder 8 more109.3732 - KaVo PROPHYflex Perio Powder (4x Fl.)110.1798 - KaVo PROPHYpearls neutral110.1798 - KaVo PROPHYpearls neutral (4x 1 Fl.)110.1826 - KaVo PROPHYpearls neutral110.1828 - KaVo PROPHYpearls mint110.1829 - KaVo PROPHYpearls peach110.1830 - KaVo PROPHYpearls orange110.1831 - KaVo PROPHYpearls black currant | 2012 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | PIEZO Cem Tip 225 - 107.4027PIEZO Endo Tip 220 - 107.4040PIEZO Endo Tip 221 - 107.4041PIEZO Endo Tip 222 - 107.4043PIEZO Implant Refill Tip Set - 107.4014PIEZO Implant Tip Set - 107.4008PIEZO Paro Tip 210 - 107.4039PIEZO Paro Tip 211 - 107.4042PIEZO Paro Tip 212 - 107.4032PIEZO Paro Tip 213 - 107.4033 170 morePIEZO Paro Tip 214 - 107.4034PIEZO Paro Tip Set - 107.4006PIEZO Prep Tip 226 - 107.4035PIEZO Prep Tip 227 - 107.4036PIEZO Prep Tip 228 - 107.4037PIEZO Prep Tip 229 - 107.4038PIEZO Scaler Tip 201 - 107.4024PIEZO Scaler Tip 202 - 107.4026PIEZO Scaler Tip 203 - 107.4028PIEZO Scaler Tip Set - 107.4004PiezoLED - 107.39950.571.5171 - SONICflex scaler Tip No. 50.571.5181 - SONICflex scaler Tip No. 60.571.5191 - SONICflex scaler Tip No. 70.571.5371 - SONICflex scaler Tip No. 80.571.5431 - SONICflex cem Tip No. 120.571.5521 - SONICflex retro Tip No. 200.571.5541 - SONICflex retro Tip No. 160.571.5561 - SONICflex retro Tip No. 210.571.5581 - SONICflex retro Tip No. 170.571.5601 - SONICflex retro, left0.571.5611 - SONICflex retro, right0.571.5621 - SONICflex rootplaner Tip No. 240.571.5631 - SONICflex rootplaner Tip No. 250.571.5641 - SONICflex rootplaner Tip No. 260.571.5651 - SONICflex rootplaner Tip No. 270.571.6731 - SONICflex micro Tip No. 290.571.6741 - SONICflex micro Tip No. 280.571.6801 - SONICflex micro Tip No. 310.571.6811 - SONICflex micro Tip No. 300.571.6821 - SONICflex micro Tip No. 330.571.6831 - SONICflex micro Tip No. 320.571.7212 - SONICflex prep gold Tip No. 490.571.7222 - SONICflex prep gold Tip No. 500.571.7262 - SONICflex prep ceram Tip No. 510.571.7272 - SONICflex prep ceram Tip No. 520.571.7322 - SONICflex retro Tip No. 560.571.7332 - SONICflex retro Tip No. 570.571.7342 - SONICflex retro Tip No. 550.571.7382 - SONICflex bevel Tip No. 590.571.7392 - SONICflex bevel Tip No. 580.571.7402 - SONICflex paro Tip No.600.571.7412 - SONICflex paro Tip No.610.571.7422 - SONICflex paro Tip No.620.571001 - SONICflex clean Brushset0.571301 - SONICflex rootplaner Tipset0.571321 - SONICflex prep gold Tipset0.571331 - SONICflex prep ceram Tipset0.571371 - SONICflex paro Tipset0.571381 - SONICflex retro Tipset0.571391 - SONICflex bevel Tipset0.571401 - SONICflex clean Tip No. 480.571402 - SONICflex clean Brush No. 10.571412 - SONICflex clean Brush No. 20.571421 - SONICflex micro Tipset0.571422 - SONICflex clean Brush No. 30.571432 - SONICflex clean Brush No. 40.571472 - SONICflex clean Brush No. 50.571482 - SONICflex clean Brush No. 6100.1980 - SONICflex cari-ex 0.8 No. 42 (A)100.1981 - SONICflex cari-ex 1.2 No. 43 (A)100.1992 - SONICflex endo Tip No. 66 (A)100.1994 - SONICflex endo Tip No. 67 (A)100.1996 - SONICflex endo Tip No. 68 (A)100.1998 - SONICflex endo Tip No. 69 (A)100.2000 - SONICflex endo Tip No. 70 (A)100.2568 - SONICflex seal Tip No. 45100.4243 - SONICflex 2003 L100.4246 - SONICflex 2003100.4983 - SONICflex scaler Tipset100.5821 - SONICflex endo Tip No. 70100.5822 - SONICflex endo Tip No. 67100.5823 - SONICflex endo Tip No. 68100.5825 - SONICflex endo Tip No. 66100.5827 - SONICflex endo Tip No. 69100.5828 - SONICflex endo Tipset100.7105 - SONICflex cari-ex 0.8 No. 42100.7167 - SONICflex cari-ex 1.2 No. 43100.7362 - SONICflex cari-ex 1 No. 71100.7363 - SONICflex cari-ex 1.4 No. 72100.7378 - SONICflex cari-ex D Tipset100.7379 - SONICflex cari-ex TC Tipset100.8333 - SONICflex 2003 L (Set)100.8334 - SONICflex 2003 (Set)102.1984 - CAD-CAM mesial gebogen No.34102.1986 - CAD-CAM distal gebogen No.35102.1988 - SONICflex prep CAD-CAM Tipset103.8167 - SONICflex implant Set103.8168 - SONICflex implant refill104.3874 - SONICflex bone Set104.3875 - SONICflex bone Tip No. 80104.3876 - SONICflex bone Tip No. 81104.3877 - SONICflex bone Tip No. 82104.3878 - SONICflex bone Tip No. 83104.3879 - SONICflex bone Tip No. 84105.8949 - SONICflex scaler Tip No. 5 (A)105.8950 - SONICflex scaler Tip No. 6 (A)105.8951 - SONICflex scaler Tip No. 7 (A)105.9310 - SONICflex 2008 L105.9311 - SONICflex 2008105.9328 - SONICflex scaler Tipset (A)106.1406 - SONICflex bone Tip No. 87106.1934 - SONICflex paro Tip No.60 (A)106.1935 - SONICflex paro Tip No.61 (A)106.1936 - SONICflex paro Tip No.62 (A)106.1953 - SONICflex scaler Tip No. 8 (A)106.1957 - SONICflex rootplaner Tip No. 24 (A)106.1959 - SONICflex rootplaner Tip No. 25 (A)106.1961 - SONICflex rootplaner Tip No. 26 (A)106.1963 - SONICflex rootplaner Tip No. 27 (A)106.1965 - SONICflex micro Tip No. 28 (A)106.1967 - SONICflex micro Tip No. 29 (A)106.1969 - SONICflex micro Tip No. 30 (A)106.1971 - SONICflex micro Tip No. 31 (A)106.1973 - SONICflex micro Tip No. 32 (A)106.1975 - SONICflex micro Tip No. 33 (A)106.1977 - SONICflex prep CAD/CAM No. 34 (A) mesial106.1979 - SONICflex prep CAD/CAM No. 35 (A) distal106.1982 - SONICflex clean Tip No.48 (A)106.1983 - SONICflex prep gold Tip No. 49 (A)106.1984 - SONICflex prep gold Tip No. 50 (A)106.1985 - SONICflex prep ceram Tip No. 51 (A)106.1986 - SONICflex prep ceram Tip No. 52 A106.1988 - SONICflex bevel Tip No. 58 (A)106.1990 - SONICflex bevel Tip No. 59 (A)106.2002 - SONICflex cari-ex 1 No. 71 (A)106.2004 - SONICflex cari-ex 1.4 No. 72 (A)106.2006 - SONICflex bone Tip No. 80 (A)106.2008 - SONICflex bone Tip No. 81 (A)106.2010 - SONICflex bone Tip No. 82 (A)106.2012 - SONICflex bone Tip No. 83 (A)106.2014 - SONICflex bone Tip No. 84 (A)106.2020 - SONICflex paro Tipset (A)106.2021 - SONICflex cemTip No. 12 (A)106.2022 - SONICflex rootplaner Tipset (A)106.2023 - SONICflex micro Tipset (A)106.2024 - SONICflex bone Tip No. 85 (A)106.2024 - SONICflex prep CAD-CAM Tipset (A)106.2025 - SONICflex bone Tip No. 86 (A)106.2025 - SONICflex cari-ex D Tipset (A) | 2012 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Operating Lights108.2700 - KaVoLUX 540 LED | 2012 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Satelec Mini LED - 103.8119 | 2017 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | 0.773000 - Multifunction LUX Syringe0.773010 - Multifunction LUX Syringe0.773500 - 3-Function Syringe0.773510 - 3-Function Syringe109.2724 - 3-Function Syringe109.7840 - 3-Function Syringe | 2012 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | 109.8757 - Tube Set S600 | 2017 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | 114.4000 - SURGmatic S15 L Pro | 2022 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | 105.5000 - COMFORTdrive System105169 - COMFORTtronic 4894107.3570 - COMFORTdrive 200XDR | 2012 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | 0.579.1000 - CORONAflex 2005 | 2012 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | 0.622.5000 - ARCUS105900 - ARCUSevo | 2012 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | 101.8748 - ELECTROtorque plus102.5015 - ELECTROtorque plus (Set)103.3490 - ELECTROtorque TLC 4893103.5622 - INTRAmatic LUX 702 KL103.5840 - ELECTROtorque TLC 4893 (Set)107150 - INTRAmatic KL 703 LED115960 - INTRA LUX KL703 LED Planmeca | 2012 |
| AirbrushKOJ · Class 2 | — | Maker | 100.5954 - RONDOflex powder 50µm (75g)100.5955 - RONDOflex powder 27µm (75g)100.5956 - RONDOflex powder 50µm (1000g)100.5957 - RONDOflex powder 27µm (1000g)102.2179 - RONDOflex plus 360 | 2012 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Lister | 105.2301 - ARCUS digma USB | 2012 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | KaVo multiCAD - 108.9312KaVo multiCAD Aufbissschienen - 109813KaVo multiCAD Eierschalenprovisorium - 109814KaVo multiCAD virtueller Artikulator ARCUSdigma - 109812KaVo multiCAD Zahnbibliothek - 110.1728 | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
KaVo Dental GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Kaltenbach & Voigt GmbH (8), Sybron Dental Specialties (4), Kavo America (4), Kaltenbach & Voigt Gmgh (1), E.M.S Electro Medical Systems S.A (1), Kaltenbach & Voigt GmbH & Co. (1), Satelec (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 2019 | K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | NTK Light Transmission Caries Detector |
| 10 Apr 2019 | K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH | EFB Dental Air-Powered Handpiece |
| 17 Mar 2017 | K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | EFA Dental Belt and/or Gear Driven Handpiece |
| 21 Feb 2017 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | EBW Handpiece and Cord Foot Controller |
| 9 Apr 2015 | K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | EFA Dental Belt and/or Gear Driven Handpiece |
| 27 Feb 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 15 Aug 2014 | K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | EBW Handpiece and Cord Foot Controller |
| 27 Sep 2013 | K130560 | MASTERTORQUE LUX 8900 L | Kaltenbach & Voigt GmbH | EFB Dental Air-Powered Handpiece |
| 24 Sep 2013 | K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | NTK Light Transmission Caries Detector |
| 19 Aug 2011 | K103027 | ELECTROTORQUE TLC | Kaltenbach & Voigt GmbH | EBW Handpiece and Cord Foot Controller |
| 14 Oct 2009 | K091091 | SONICFILL 2010 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 4 Sep 2008 | K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | Sybron Dental Specialties | ELC Ultrasonic Scaler |
| 3 Sep 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties | EFB Dental Air-Powered Handpiece |
| 6 Jun 2008 | K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | Kaltenbach & Voigt GmbH & Co. | EIA Operative Dental Unit |
| 19 Jul 2007 | K071288 | MODIFICATION TO KAVO QUATTROCARE | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 2 Aug 2005 | K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America | NBL Light-Induced Fluorescence Caries Detector |
| 23 Nov 2004 | K042872 | RONDOFLEX PLUS 360 | Kavo America | KOJ Airbrush |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 9 Jul 2003 | K031868 | PROPHYPEARLS | Kavo America | EFB Dental Air-Powered Handpiece |
| 22 Feb 2000 | DEN990002 | KAVO DIAGNODENT | Kavo America | NBL Light-Induced Fluorescence Caries Detector |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KAVO DENTAL GMBHFDA reg. 3003637274 | WARTHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer, Foreign exporter, Manufacturer, Specification developer |
| KAVO DENTAL GMBHFDA reg. 8010493 | BIBERACH Baden-Wurttemberg, Germany | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042139). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.