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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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Soprano® 10 Gingiva brown (25 g)
Cendres+Métaux SA
08058756
In Commercial Distribution

  • 07640239932272 ()
08058756

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva brown (15 g)
Cendres+Métaux SA
08058755
In Commercial Distribution

  • 07640239932265 ()
08058755

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva violet (25 g)
Cendres+Métaux SA
08058754
In Commercial Distribution

  • 07640239932258 ()
08058754

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva violet (15 g)
Cendres+Métaux SA
08058753
In Commercial Distribution

  • 07640239932241 ()
08058753

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva orange (25 g)
Cendres+Métaux SA
08058752
In Commercial Distribution

  • 07640239932234 ()
08058752

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva orange (15 g)
Cendres+Métaux SA
08058751
In Commercial Distribution

  • 07640239932227 ()
08058751

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark-intense (40 g)
Cendres+Métaux SA
08058750
In Commercial Distribution

  • 07640239932210 ()
08058750

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark-intense (25 g)
Cendres+Métaux SA
08058749
In Commercial Distribution

  • 07640239932203 ()
08058749

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark-intense (15 g)
Cendres+Métaux SA
08058748
In Commercial Distribution

  • 07640239932197 ()
08058748

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark (40 g)
Cendres+Métaux SA
08058747
In Commercial Distribution

  • 07640239932180 ()
08058747

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark (25 g)
Cendres+Métaux SA
08058746
In Commercial Distribution

  • 07640239932173 ()
08058746

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark (15 g)
Cendres+Métaux SA
08058745
In Commercial Distribution

  • 07640239932166 ()
08058745

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva light (40 g)
Cendres+Métaux SA
08058744
In Commercial Distribution

  • 07640239932159 ()
08058744

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva light (25 g)
Cendres+Métaux SA
08058743
In Commercial Distribution

  • 07640239932142 ()
08058743

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva light (15 g)
Cendres+Métaux SA
08058742
In Commercial Distribution

  • 07640239932135 ()
08058742

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva orange 5g
Cendres+Métaux SA
08058201
In Commercial Distribution

  • 07640239930049 ()
08058201

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva light
Cendres+Métaux SA
08058200
In Commercial Distribution

  • 07640239930032 ()
08058200

  • Dental appliance fabrication material, ceramic
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-10P
In Commercial Distribution

  • 00816125023400 ()
OB-10P

  • Bone matrix implant, synthetic, non-antimicrobial
Soprano®10 Enamel EO 100g
Cendres+Métaux SA
08057783
In Commercial Distribution

  • 07640173096559 ()
08057783

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel EO 40g
Cendres+Métaux SA
08057782
In Commercial Distribution

  • 07640173096542 ()
08057782

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Enamel 2 100g
Cendres+Métaux SA
08057781
In Commercial Distribution

  • 07640173096535 ()
08057781

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Enamel 2 40g
Cendres+Métaux SA
08057780
In Commercial Distribution

  • 07640173096528 ()
08057780

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Enamel 1 100g
Cendres+Métaux SA
08057779
In Commercial Distribution

  • 07640173096511 ()
08057779

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Enamel 1 40g
Cendres+Métaux SA
08057778
In Commercial Distribution

  • 07640173096504 ()
08057778

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 4 100g
Cendres+Métaux SA
08057762
In Commercial Distribution

  • 07640173096498 ()
08057762

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 4 40g
Cendres+Métaux SA
08057761
In Commercial Distribution

  • 07640173096481 ()
08057761

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 3 100g
Cendres+Métaux SA
08057767
In Commercial Distribution

  • 07640173096474 ()
08057767

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 3 40g
Cendres+Métaux SA
08057766
In Commercial Distribution

  • 07640173096467 ()
08057766

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 2 100g
Cendres+Métaux SA
08057777
In Commercial Distribution

  • 07640173096450 ()
08057777

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 2 40g
Cendres+Métaux SA
08057776
In Commercial Distribution

  • 07640173096443 ()
08057776

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 1 100g
Cendres+Métaux SA
08057775
In Commercial Distribution

  • 07640173096436 ()
08057775

  • Dental appliance fabrication material, ceramic
Soprano®10 Bleach Dentine 1 40g
Cendres+Métaux SA
08057774
In Commercial Distribution

  • 07640173096429 ()
08057774

  • Dental appliance fabrication material, ceramic
Soprano®10 Frame Modifier pink 5g
Cendres+Métaux SA
08057773
In Commercial Distribution

  • 07640173096412 ()
08057773

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel E2 100g
Cendres+Métaux SA
08057772
In Commercial Distribution

  • 07640173096405 ()
08057772

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel E2 40g
Cendres+Métaux SA
08057771
In Commercial Distribution

  • 07640173096399 ()
08057771

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel E1 100g
Cendres+Métaux SA
08057770
In Commercial Distribution

  • 07640173096382 ()
08057770

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel E1 40g
Cendres+Métaux SA
08057769
In Commercial Distribution

  • 07640173096375 ()
08057769

  • Dental appliance fabrication material, ceramic
Soprano®10 Dentine B1 25g
Cendres+Métaux SA
08057768
In Commercial Distribution

  • 07640173096368 ()
08057768

  • Dental appliance fabrication material, ceramic
Soprano®10 Dentine B0 25g
Cendres+Métaux SA
08057765
In Commercial Distribution

  • 07640173096351 ()
08057765

  • Dental appliance fabrication material, ceramic
Soprano®10 Dentine A2 25g
Cendres+Métaux SA
08057764
In Commercial Distribution

  • 07640173096344 ()
08057764

  • Dental appliance fabrication material, ceramic
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