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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. 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

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

Millennium - 00190776166113

PIERCE Cheek Retractor . Blade is
Avalign Technologies, Inc.
1-24160
In Commercial Distribution

  • 00190776166113 ()


  • Hand-held surgical retractor, reusable

Neobiotech Implant System - 08800329740104

IS, Ø5.0, Hex, R/W
Neobiotech. co., ltd
ISSB5011
In Commercial Distribution

  • 08800329740104 ()


  • Dental implant system

Neobiotech Implant System - 08800329740067

IS, Ø5.0, Hex, R/W
Neobiotech. co., ltd
ISSB5011P
In Commercial Distribution

  • 08800329740067 ()


  • Dental implant system

Gyrus ACMI - 00821925024137

VOKOVIC I-S JOINT REPLACEMENT PLASTIPORE
Gyrus ACMI, LLC
912986
Not in Commercial Distribution

  • 00821925024137 ()


  • Ossicular prosthesis, partial

iClean - 26974488990062

The breaking point is 90mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 36974488990069 ()
  • 26974488990062 ()
  • 16974488990065 ()


  • General-purpose absorbent tip applicator/swab, single-use

iClean - 16974488990096

The breaking point is 80mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 26974488990093 ()
  • 16974488990096 ()
  • 06974488990099 ()


  • General-purpose absorbent tip applicator/swab, single-use

Lumecca I - 07290016633955

Lumecca-I is an IPL applicator
INMODE M.D LTD
AG610797A
In Commercial Distribution

  • 07290016633955 ()
AG610797A

  • Multi-modality skin surface treatment system
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