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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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INTRAmatic 31 ES - EKAV100311090

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1109
In Commercial Distribution

  • EKAV100311090 ()
31 ES

  • Dental power tool system handpiece, line-powered

INTRAmatic 20 E - EKAV100311070

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered

INTRA Handpiece CL 3-09 - EKAV100236930

This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.3693
In Commercial Distribution

  • EKAV100236930 ()
CL 3 09

  • Dental power tool system handpiece, line-powered

RONDOflex plus 360 - EKAV100221790

This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.2179
In Commercial Distribution

  • EKAV100221790 ()
plus 360

  • Dental power tool system handpiece, line-powered

INTRA Handpiece CL 10 - EKAV100209110

This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.0911
In Commercial Distribution

  • EKAV100209110 ()
CL 10

  • Dental power tool system handpiece, line-powered

INTRA Head CL 3 - EKAV100189930

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.8993
In Commercial Distribution

  • EKAV100189930 ()
CL 3

  • Dental power tool system handpiece, line-powered

GENTLEpower LUX 20 LP - EKAV100174530

No Description
KaVo Dental GmbH
1.001.7453
In Commercial Distribution

  • EKAV100174530 ()
20 LP

  • Dental power tool system handpiece, line-powered

INTRA Head C 3 - EKAV100145030

No Description
KaVo Dental GmbH
1.001.4503
In Commercial Distribution

  • EKAV100145030 ()
C 3

  • Dental power tool system handpiece, line-powered

INTRA Handpiece C09 - EKAV100122780

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.2278
In Commercial Distribution

  • EKAV100122780 ()
C09

  • Dental power tool system handpiece, line-powered

SURGmatic Head S201 L Pro - EKAV101386480

No Description
KaVo Dental GmbH
1.013.8648
In Commercial Distribution

  • EKAV101386480 ()
Head S201 L Pro

  • Dental power tool system handpiece, line-powered

SMARTmatic S53 - EKAV101168100

No Description
KaVo Dental GmbH
1.011.6810
In Commercial Distribution

  • EKAV101168100 ()
S53

  • Dental power tool system handpiece, line-powered

SMARTmatic ENDO S321 - EKAV101167900

This is a medical device.
KaVo Dental GmbH
1.011.6790
In Commercial Distribution

  • EKAV101167900 ()
S321

  • Dental power tool system handpiece, line-powered

SMARTmatic ENDO S81 - EKAV101167800

This is an medical device.
KaVo Dental GmbH
1.011.6780
In Commercial Distribution

  • EKAV101167800 ()
ENDO S81

  • Dental power tool system handpiece, line-powered

SMARTmatic S20 K - EKAV101167510

No Description
KaVo Dental GmbH
1.011.6751
In Commercial Distribution

  • EKAV101167510 ()
S20 K

  • Dental power tool system handpiece, line-powered

SMARTmatic PROPHY S19 K - EKAV101167410

No Description
KaVo Dental GmbH
1.011.6741
In Commercial Distribution

  • EKAV101167410 ()
S19 K

  • Dental power tool system handpiece, line-powered

SMARTmatic PROPHY S19 - EKAV101167400

No Description
KaVo Dental GmbH
1.011.6740
In Commercial Distribution

  • EKAV101167400 ()
S19

  • Dental power tool system handpiece, line-powered

SMARTmatic S10 S - EKAV101167320

No Description
KaVo Dental GmbH
1.011.6732
In Commercial Distribution

  • EKAV101167320 ()
S10 S

  • Dental power tool system handpiece, line-powered

SMARTmatic S10 K - EKAV101167310

No Description
KaVo Dental GmbH
1.011.6731
In Commercial Distribution

  • EKAV101167310 ()
S10 K

  • Dental power tool system handpiece, line-powered

Reducing Head S201X - EKAV101030000

No Description
KaVo Dental GmbH
1.010.3000
In Commercial Distribution

  • EKAV101030000 ()
S201X

  • Dental power tool system handpiece, line-powered

SURGmatic S201 XL - EKAV101023320

No Description
KaVo Dental GmbH
1.010.2332
In Commercial Distribution

  • EKAV101023320 ()
S201 XL

  • Dental power tool system handpiece, line-powered

Replacement Head S201 - EKAV100981470

No Description
KaVo Dental GmbH
1.009.8147
In Commercial Distribution

  • EKAV100981470 ()
S201

  • Dental power tool system handpiece, line-powered

MASTERmatic LUX M05 L - EKAV100936400

This is a medical device.
KaVo Dental GmbH
1.009.3640
In Commercial Distribution

  • EKAV100936400 ()
M05 L

  • Dental power tool system handpiece, line-powered

MASTERmatic LUX M25 L - EKAV100936300

This is a medical device.
KaVo Dental GmbH
1.009.3630
In Commercial Distribution

  • EKAV100936300 ()
M25 L

  • Dental power tool system handpiece, line-powered

MASTERmatic LUX M07 L - EKAV100936100

This is a medical device.
KaVo Dental GmbH
1.009.3610
In Commercial Distribution

  • EKAV100936100 ()
M07 L

  • Dental power tool system handpiece, line-powered

MASTERmatic LUX M29 L - EKAV100935800

This is a medical device.
KaVo Dental GmbH
1.009.3580
In Commercial Distribution

  • EKAV100935800 ()
M29 L

  • Dental power tool system handpiece, line-powered

MASTERmatic LUX M10 L - EKAV100935700

This is a medical device.
KaVo Dental GmbH
1.009.3570
In Commercial Distribution

  • EKAV100935700 ()
M10 L

  • Dental power tool system handpiece, line-powered

SURGmatic S201 C - EKAV100911000

No Description
KaVo Dental GmbH
1.009.1100
In Commercial Distribution

  • EKAV100911000 ()
S201 C

  • Dental power tool system handpiece, line-powered

SURGmatic S11 C - EKAV100910050

No Description
KaVo Dental GmbH
1.009.1005
In Commercial Distribution

  • EKAV100910050 ()
S11 C

  • Dental power tool system handpiece, line-powered

SURGmatic S201 L - EKAV100904700

No Description
KaVo Dental GmbH
1.009.0470
In Commercial Distribution

  • EKAV100904700 ()
S201 L

  • Dental power tool system handpiece, line-powered

EXPERTmatic E61 C - EKAV100849990

No Description
KaVo Dental GmbH
1.008.4999
In Commercial Distribution

  • EKAV100849990 ()
E61 C

  • Dental power tool system handpiece, line-powered

EXPERTmatic E31 C - EKAV100849980

No Description
KaVo Dental GmbH
1.008.4998
In Commercial Distribution

  • EKAV100849980 ()
E31 C

  • Dental power tool system handpiece, line-powered

INTRA Micro Kopf L22 - EKAV100818350

No Description
KaVo Dental GmbH
1.008.1835
In Commercial Distribution

  • EKAV100818350 ()
L22

  • Dental power tool system handpiece, line-powered

INTRA Kopf L68 B - EKAV100818340

No Description
KaVo Dental GmbH
1.008.1834
In Commercial Distribution

  • EKAV100818340 ()
L68 B

  • Dental power tool system handpiece, line-powered

INTRA Kopf L68 - EKAV100818330

No Description
KaVo Dental GmbH
1.008.1833
In Commercial Distribution

  • EKAV100818330 ()
L68

  • Dental power tool system handpiece, line-powered

INTRA Kopf L67 - EKAV100818320

This is a medical device.This is a medical device.
KaVo Dental GmbH
1.008.1832
In Commercial Distribution

  • EKAV100818320 ()
L67

  • Dental power tool system handpiece, line-powered

INTRA Kopf L66 B - EKAV100818310

No Description
KaVo Dental GmbH
1.008.1831
In Commercial Distribution

  • EKAV100818310 ()
L66 B

  • Dental power tool system handpiece, line-powered

INTRA Kopf L62 - EKAV100818300

No Description
KaVo Dental GmbH
1.008.1830
In Commercial Distribution

  • EKAV100818300 ()
L62

  • Dental power tool system handpiece, line-powered

INTRA EVA Kopf L61 R - EKAV100818290

No Description
KaVo Dental GmbH
1.008.1829
In Commercial Distribution

  • EKAV100818290 ()
L61 R

  • Dental power tool system handpiece, line-powered

INTRA Endo Kopf L53 - EKAV100818260

No Description
KaVo Dental GmbH
1.008.1826
In Commercial Distribution

  • EKAV100818260 ()
L53

  • Dental power tool system handpiece, line-powered

INTRA Mini Kopf L52 - EKAV100818250

No Description
KaVo Dental GmbH
1.008.1825
In Commercial Distribution

  • EKAV100818250 ()
L52

  • Dental power tool system handpiece, line-powered
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