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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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Artic digital 8, A3 / 20 degrees-30LD, CE - J014660806610

Artifical Teeth, resin
Kulzer GmbH
66080661
In Commercial Distribution

  • J014660806610 ()
66080661

  • Resin artificial teeth

Artic digital 8, A2 / 20 degrees-30LD, CE - J014660806510

Artifical Teeth, resin
Kulzer GmbH
66080651
In Commercial Distribution

  • J014660806510 ()
66080651

  • Resin artificial teeth

Artic digital 8, A1 / 20 degrees-30LD, CE - J014660806410

Artifical Teeth, resin
Kulzer GmbH
66080641
In Commercial Distribution

  • J014660806410 ()
66080641

  • Resin artificial teeth

HC-Zirkonia Schneide Bleach S BL, 20 g. - J014660218920

Porcelain Powder for clinical use.
Kulzer GmbH
66021891
Not in Commercial Distribution

  • J014660218920 ()
66021891

  • Dental appliance fabrication material, ceramic

HC-Zirkonia Dentin Bleach D BL3, 20 g. - J014660218910

Porcelain Powder for clinical use.
Kulzer GmbH
66021858
Not in Commercial Distribution

  • J014660218910 ()
66021858

  • Dental appliance fabrication material, ceramic

HeraCeram Schneide Bleach S BL, 20 g. - J014660155910

Porcelain Powder for clinical use.
Kulzer GmbH
66015590
Not in Commercial Distribution

  • J014660155910 ()
66015590

  • Dental appliance fabrication material, ceramic

HeraCeram Dentin Bleach D BL1, 20 g. - J014660155900

Porcelain Powder for clinical use.
Kulzer GmbH
66015589
Not in Commercial Distribution

  • J014660155900 ()
66015589

  • Dental appliance fabrication material, ceramic

SET PROIMPLANT 3RD GEN CA 20:1 - J00717007740011

Sets of Proimplant systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700774-001
In Commercial Distribution

  • J00717007740011 ()
1700774-001

  • Surgical power tool system control unit, line-powered

Set Osseocare CA 20:1 L MS - J00717004720011

Set of Osseocare system and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700472-001
In Commercial Distribution

  • J00717004720011 ()
1700472-001

  • Surgical power tool system control unit, line-powered

Set iChiropro + CA 20:1 L MS - J00717004400011

Sets of iChiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700440-001
In Commercial Distribution

  • J00717004400011 ()
1700440-001

  • Surgical power tool system control unit, line-powered
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