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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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Creation Willi Geller - ECWG0002061

CC/ Opaque O-B1
KLEMA Dentalprodukte GmbH
000206
In Commercial Distribution

  • ECWG0002061 ()
000206

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002051

CC/ Opaque O-A4
KLEMA Dentalprodukte GmbH
000205
In Commercial Distribution

  • ECWG0002051 ()
000205

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002031

CC/ Opaque O-A3
KLEMA Dentalprodukte GmbH
000203
In Commercial Distribution

  • ECWG0002031 ()
000203

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002021

CC/ Opaque O-A2
KLEMA Dentalprodukte GmbH
000202
In Commercial Distribution

  • ECWG0002021 ()
000202

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0001741

CC/ Glaze GL
KLEMA Dentalprodukte GmbH
000174
In Commercial Distribution

  • ECWG0001741 ()
000174

  • Dental appliance fabrication material, ceramic

Inion BioRestore™ - M224BRS54319

Morsels 4.5 cc
Inion Oy
1
In Commercial Distribution

  • M224BRS54319 ()
BRS-5431

  • Synthetic bone graft

Inion BioRestore™ - M224BRS54309

Morsels 1.5 cc
Inion Oy
1
In Commercial Distribution

  • M224BRS54309 ()
BRS-5430

  • Synthetic bone graft

Inion OTPS BioRestore™ - M224BRS16119

Morsels 1.5 cc
Inion Oy
1
In Commercial Distribution

  • M224BRS16119 ()
BRS-1611

  • Synthetic bone graft

Inion OTPS BioRestore™ - M224BRS16109

Morsels 4.5 cc
Inion Oy
1
In Commercial Distribution

  • M224BRS16109 ()
BRS-1610

  • Synthetic bone graft

Osseolive Dental - ECURL20M0250

Device Name: Curasan OSSEOLIVE® DENTAL lndications for Use: OSSEOLIVE® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.: - Defects after the extirpation of bone cysts - Augmentation of an atrophied alveolar ridge - Sinus lift or sinus floor elevation (subantral augmentation) - Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge - Filling of extraction defects to create an implant bed - Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects - Defects after operative removal of retained teeth or corrective osteotomies
curasan AG
250-1000µm
In Commercial Distribution

  • ECURL20M0250 ()
  • ECURL20M02505 ()
5x2.0 cc

  • Dental bone matrix implant, synthetic
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