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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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SONICflex rootplaner Tip No. 26 (A) - EKAV100619610

This is a medical device.
KaVo Dental GmbH
1.006.1961
In Commercial Distribution

  • EKAV100619610 ()
rootplaner Tip No 26 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 25 (A) - EKAV100619590

This is a medical device.
KaVo Dental GmbH
1.006.1959
In Commercial Distribution

  • EKAV100619590 ()
rootplaner Tip No 25 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 24 (A) - EKAV100619570

This is a medical device.
KaVo Dental GmbH
1.006.1957
In Commercial Distribution

  • EKAV100619570 ()
rootplaner Tip No 24 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 62 (A) - EKAV100619360

This is a medical device.
KaVo Dental GmbH
1.006.1936
In Commercial Distribution

  • EKAV100619360 ()
paro Tip No 62 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 60 (A) - EKAV100619340

This is a medical device.
KaVo Dental GmbH
1.006.1934
In Commercial Distribution

  • EKAV100619340 ()
paro Tip No 60 A

  • Dental surgical power tool motor, pneumatic

EXPERTtorque Mini LUX E677 LN - EKAV100601000

This is a medical device.
KaVo Dental GmbH
1.006.0100
In Commercial Distribution

  • EKAV100601000 ()
E677 LN

  • Dental surgical power tool motor, pneumatic

SONICflex scaler Tip No. 6 (A) - EKAV100589500

This is a medical device.
KaVo Dental GmbH
1.005.8950
In Commercial Distribution

  • EKAV100589500 ()
scaler Tip No 6 A

  • Ultrasonic dental scaling/debridement system

SONICflex scaler Tip No. 5 (A) - EKAV100589490

This is a medical device.
KaVo Dental GmbH
1.005.8949
In Commercial Distribution

  • EKAV100589490 ()
scaler Tip No 5 A

  • Ultrasonic dental scaling/debridement system

ARCUS digma USB - EKAV100523010

This is a medical device.
KaVo Dental GmbH
1.005.2301
In Commercial Distribution

  • EKAV100523010 ()
NA

  • Facebow

COMFORTtronic 4894 - EKAV100501690

This is a medical device.
KaVo Dental GmbH
1.005.0169
In Commercial Distribution

  • EKAV100501690 ()
4894

  • Dental delivery system

DIAGNOdent Display 2191 - EKAV100484000

This is a medical device.
KaVo Dental GmbH
1.004.8400
In Commercial Distribution

  • EKAV100484000 ()
2191

  • Dental caries detector, optical induced fluorescence

INTRAmatic 80 ES - EKAV100443750

This is a medical device.
KaVo Dental GmbH
1.004.4375
In Commercial Distribution

  • EKAV100443750 ()
80 ES

  • Dental power tool system handpiece, line-powered

DIAGNOdent pen 2190 US - EKAV100434000

This is a medical device.
KaVo Dental GmbH
1.002.7000
In Commercial Distribution

  • EKAV100434000 ()
2190 US

  • Dental caries detector, optical induced fluorescence

SONICflex clean Tip No. 48 - EKAV100381670

This is a medical device.
KaVo Dental GmbH
0.571.0401
In Commercial Distribution

  • EKAV100381670 ()
clean Tip No 48

  • Ultrasonic dental scaling/debridement system

INTRAmatic 10 E - EKAV100369770

This is a medical device.
KaVo Dental GmbH
1.003.6977
In Commercial Distribution

  • EKAV100369770 ()
10 E

  • Dental power tool system handpiece, line-powered

ELECTROtorque TLC 4893 (Set) - EKAV100358400

This is a medical device.
KaVo Dental GmbH
1.003.5840
In Commercial Distribution

  • EKAV100358400 ()
TLC 4893 Set

  • Dental delivery system

ELECTROtorque TLC 4893 - EKAV100334900

This is a medical device.
KaVo Dental GmbH
1.003.3490
In Commercial Distribution

  • EKAV100334900 ()
TLC 4893

  • Dental delivery system

PROPHYwiz 181 P - EKAV100322780

This is a medical device.
KaVo Dental GmbH
1.003.2278
In Commercial Distribution

  • EKAV100322780 ()
181 P

  • Dental power tool system handpiece, pneumatic

DIAGNOdent pen 2190 - EKAV100270000

This is a medical device.
KaVo Dental GmbH
1.002.7000
In Commercial Distribution

  • EKAV100270000 ()
2190

  • Dental caries detector, optical induced fluorescence

ELECTROtorque plus (Set) - EKAV100250150

This is a medical device.
KaVo Dental GmbH
1.002.5015
In Commercial Distribution

  • EKAV100250150 ()
plus Set

  • Dental delivery system

SONICflex prep CAD-CAM Tipset - EKAV100219880

This is a medical device.
KaVo Dental GmbH
1.002.1988
In Commercial Distribution

  • EKAV100219880 ()
prep CAD CAM Tipset

  • Ultrasonic dental scaling/debridement system

ELECTROtorque plus - EKAV100187480

This is a medical device.
KaVo Dental GmbH
1.001.8748
In Commercial Distribution

  • EKAV100187480 ()
plus

  • Dental delivery system

GENTLEpower LUX 10 LP - EKAV100156600

This is a medical device.
KaVo Dental GmbH
1.001.5660
In Commercial Distribution

  • EKAV100156600 ()
10 LP

  • Dental surgical power tool motor, electric

SONICflex cari-ex 0.8 No. 42 - EKAV100071050

This is a medical device.
KaVo Dental GmbH
1.000.7105
In Commercial Distribution

  • EKAV100071050 ()
cari ex 0 8 No 42

  • Ultrasonic dental scaling/debridement system

RONDOflex powder 27m (1000g) - EKAV100059570

This is a medical device.
KaVo Dental GmbH
1.000.5957
In Commercial Distribution

  • EKAV100059570 ()
NA

  • Dental abrasive powder

RONDOflex powder 50m (75g) - EKAV100059540

This is a medical device.
KaVo Dental GmbH
1.000.5954
In Commercial Distribution

  • EKAV100059540 ()
NA

  • Dental abrasive powder

SONICflex endo Tipset - EKAV100058280

This is a medical device.
KaVo Dental GmbH
1.000.5828
In Commercial Distribution

  • EKAV100058280 ()
endo Tipset

  • Ultrasonic dental scaling/debridement system

SONICflex endo Tip No. 66 - EKAV100058250

This is a medical device.
KaVo Dental GmbH
1.000.5825
In Commercial Distribution

  • EKAV100058250 ()
endo Tip No 66

  • Ultrasonic dental scaling/debridement system

SONICflex endo Tip No. 68 - EKAV100058230

This is a medical device.
KaVo Dental GmbH
1.000.5823
In Commercial Distribution

  • EKAV100058230 ()
endo Tip No 68

  • Ultrasonic dental scaling/debridement system

PROPHYflex 3 2018 black - EKAV100046720

This is a medical device.
KaVo Dental GmbH
1.000.4672
In Commercial Distribution

  • EKAV100046720 ()
3 2018 black

  • Dentifrice

ARCUS - EKAV062250000

This is a medical device.
KaVo Dental GmbH
0.622.5000
In Commercial Distribution

  • EKAV062250000 ()
NA

  • Facebow

DIAGNOdent 2095 - EKAV057405000

This is a medical device.
KaVo Dental GmbH
0.574.0500
In Commercial Distribution

  • EKAV057405000 ()
2095

  • Dental caries detector, optical induced fluorescence

SONICflex rootplaner Tip No. 27 - EKAV057156510

This is a medical device.
KaVo Dental GmbH
0.571.5651
In Commercial Distribution

  • EKAV057156510 ()
rootplaner Tip No 27

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 24 - EKAV057156210

This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system

SONICflex bevel Tipset - EKAV057103910

This is a medical device.
KaVo Dental GmbH
0.571.0391
In Commercial Distribution

  • EKAV057103910 ()
bevel Tipset

  • Ultrasonic dental scaling/debridement system

INTRAflex LUX2 2313 LN - EKAV053562200

This is a medical device.
KaVo Dental GmbH
0.535.6220
In Commercial Distribution

  • EKAV053562200 ()
2313 LN

  • Dental power tool system handpiece, pneumatic

INTRA Surgery Handpiece 3624 N - EKAV053456600

This is a medical device.
KaVo Dental GmbH
0.534.5660
In Commercial Distribution

  • EKAV053456600 ()
3624 N

  • Dental power tool system handpiece, line-powered

INTRA Surgery Handpiece 3620 N - EKAV053456500

This is a medical device.
KaVo Dental GmbH
0.534.5650
In Commercial Distribution

  • EKAV053456500 ()
3620 N

  • Dental surgical power tool motor, electric

KaVo Spray AMERICA 2113 (Set) - EKAV041196600

This is a medical device.
KaVo Dental GmbH
0.411.9660
In Commercial Distribution

  • EKAV041196600 ()
2113 Set

  • Dental handpiece maintenance unit

KaVo Spray AMERICA 2113 - EKAV041196500

This is a medical device.
KaVo Dental GmbH
0.411.9650
In Commercial Distribution

  • EKAV041196500 ()
AMERICA 2113

  • Surgical instrument maintenance lubricant

PIEZOsoft - EKAV100984880

This is a medical device.
KaVo Dental GmbH
1.009.8488
In Commercial Distribution

  • EKAV100984880 ()
N.A.

  • Ultrasonic dental scaling/debridement system

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 M20 L - EKAV100936200

This is a medical device.
KaVo Dental GmbH
1.009.3620
In Commercial Distribution

  • EKAV100936200 ()
M20 L

  • Dental surgical power tool motor, electric

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

MASTERsurg LUX Wireless - EKAV100912000

This is a medical device.
KaVo Dental GmbH
1.009.1200
In Commercial Distribution

  • EKAV100912000 ()
NA

  • Dental delivery system

SONICflex prep crown plain no. 98 A - EKAV100863860

This is a medical device.
KaVo Dental GmbH
1.008.6386
In Commercial Distribution

  • EKAV100863860 ()
1.008.6386

  • Ultrasonic dental scaling/debridement system

SONICflex prep crown round no. 97 A - EKAV100863840

This is a medical device
KaVo Dental GmbH
1.008.6384
In Commercial Distribution

  • EKAV100863840 ()
1.008.6384

  • Ultrasonic dental scaling/debridement system
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