FDA.report

Straumann Boneceramic

Primary DI
07630031736451
Brand
Straumann Boneceramic
Company
Institut Straumann AG
Model
BoneCeramic
Catalog number
070.198
Device description
Straumann® BoneCeramic™, 0.4-0.7mm, ~0.3cc, 0.25g
Published
2022-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYCBone grafting material, synthetic

Product Code Classifications

CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031736451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031736451076300317364517630031736451

GMDN Terms

TermDefinition
Dental bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)448-8168info.usa@straumann.com

Regulatory Flags

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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07630031772725NAsurgically Invasive Instruments044.783S2026-03-04
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07630031772763NAsurgically Invasive Instruments044.787S2026-03-04
07630031772770NAsurgically Invasive Instruments044.788S2026-03-04
07630031772787NAsurgically Invasive Instruments044.789S2026-03-04
07630031772794NAsurgically Invasive Instruments044.790S2026-03-04
07630031772800NAsurgically Invasive Instruments044.791S2026-03-04
07630031772817NAsurgically Invasive Instruments044.792S2026-03-04
07630031772824NAsurgically Invasive Instruments044.793S2026-03-04
07630031772831NAsurgically Invasive Instruments044.794S2026-03-04
07630031772848NAsurgically Invasive Instruments044.795S2026-03-04
07630031772855NAsurgically Invasive Instruments044.796S2026-03-04
07630031772862NAsurgically Invasive Instruments044.797S2026-03-04
07630031772879NAsurgically Invasive Instruments066.1101S2026-03-04

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10813954028566bioKOTECOLLAGEN MATRIX, INC.LYC2026-03-09
14550565002269Cytrans GranulesGc America Inc.LYC2026-03-03
14550565002276Cytrans GranulesGc America Inc.LYC2026-03-03
D047014615Cytrans GranulesGc America Inc.LYC2026-03-03
D047014616Cytrans GranulesGc America Inc.LYC2026-03-03
07290014838116Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838123Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381783D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382153D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
00813954028392SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028408SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028415SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028422SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909013756Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013329Dental Putty Syringe 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013343Dental Putty Syringe 2.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013558Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013565Dental Putty Cartridge 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013527PerioGlas - 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013534PerioGlas 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013497Dental Putty 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013541Dental Putty - 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25