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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. 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 clean Brush No. 4 - EKAV057104320

This is a medical device.
KaVo Dental GmbH
0.571.0432
In Commercial Distribution

  • EKAV057104320 ()
clean Brush No 4

  • 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

SONICflex rootplaner Tipset - EKAV057103010

This is a medical device.
KaVo Dental GmbH
0.571.0301
In Commercial Distribution

  • EKAV057103010 ()
rootplaner 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 L-LUX 181 L - EKAV053552100

This is a medical device.
KaVo Dental GmbH
0.535.5210
In Commercial Distribution

  • EKAV053552100 ()
181 L

  • Remotely-driven dental drilling system motor

INTRA-L-MOTOR 181 H - EKAV053552000

This is a medical device.
KaVo Dental GmbH
0.535.5200
In Commercial Distribution

  • EKAV053552000 ()
181 H

  • Remotely-driven dental drilling system motor

INTRA Surgery Handpiece 3630 N - EKAV053456700

This is a medical device.
KaVo Dental GmbH
0.534.5670
In Commercial Distribution

  • EKAV053456700 ()
3630 N

  • Dental surgical power tool motor, electric

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

INTRA Surgery Handpiece 3610 N3 - EKAV052456200

This is a medical device.
KaVo Dental GmbH
0.524.5620
In Commercial Distribution

  • EKAV052456200 ()
3610 N3

  • Dental power tool system handpiece, line-powered

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

Packaged System, Kavo Nomad Pro2, GBL - EKAV101320410

this is a medical device
ARIBEX, INC.
1.013.2041
In Commercial Distribution

  • EKAV101320410 ()
1.013.2041

  • Diagnostic x-ray system generator, hand-held

Packaged System, Kavo Nomad Pro2, US - EKAV101320400

This is a medical device.
ARIBEX, INC.
1.013.2040
In Commercial Distribution

  • EKAV101320400 ()
1.013.2040

  • Diagnostic x-ray system generator, hand-held

PROPHYflex 4 Wave - EKAV101194030

This is a medical device.
KaVo Dental GmbH
1.011.9403
In Commercial Distribution

  • EKAV101194030 ()
4 Perio Kit

  • Dental abrasive air jet system handpiece

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

Elements 8:1 - EKAV101167860

This is a medical device.
KaVo Dental GmbH
1.011.6786
In Commercial Distribution

  • EKAV101167860 ()
8:1

  • 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 PROPHY S31 - EKAV101167600

This is a medical device.
KaVo Dental GmbH
1.011.6760
In Commercial Distribution

  • EKAV101167600 ()
S31

  • Dental surgical power tool motor, electric

SM5 - EKAV101149000

This is a medical device.
KaVo Dental GmbH
1.011.4900
In Commercial Distribution

  • EKAV101149000 ()
NA

  • Dental delivery system

MASTERtorque Mini Kids Edition (en) - EKAV101123300

This is a medical device.
KaVo Dental GmbH
1.011.2330
In Commercial Distribution

  • EKAV101123300 ()
Kids-Edition en

  • Dental power tool system handpiece, pneumatic

DEXIS CariVu - EKAV101055700

This is a medical device.
KaVo Dental GmbH
1.010.5570
In Commercial Distribution

  • EKAV101055700 ()
NA

  • Dental caries detector, optical induced fluorescence

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
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