FDA.reportPublic FDA data

Karl Schumacher Composite Putty

Primary DI
00842517102309
Brand
Karl Schumacher Composite Putty
Company
KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
Model
RCBP0050
Device description
Regenerative Collagen Dental Bone Graft Composite
Published
2017-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517102309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517102309008425171023098425171023090842517102309

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043957315
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517100008Karl SchumacherSYR00012016-09-27
00842517102545Karl Schumacher17.007.012023-11-14
00842517102552Karl Schumacher17.007.022023-11-14
00842517102569Karl Schumacher17.007.032023-11-14
00842517102576Karl Schumacher17.007.042023-11-14
00842517102583Karl Schumacher17.007.052023-11-14
00842517102590Karl Schumacher17.007.05AE2023-11-14
00842517102613Karl Schumacher17.008.012023-11-14
00842517102620Karl Schumacher17.008.022023-11-14
00842517102637Karl Schumacher17.008.032023-11-14
00842517102644Karl Schumacher17.008.042023-11-14
00842517102651Karl Schumacher17.008.052023-11-14
00842517102668Karl Schumacher17.008.05AE2023-11-14
00842517102675Karl Schumacher17.008.062023-11-14
00842517102682Karl Schumacher17.008.06AE2023-11-14
00842517102699Karl Schumacher17.008.082023-11-14
00842517102705Karl Schumacher17.008.08AE2023-11-14
00842517102712Karl Schumacher17.008.092023-11-14
00842517102729Karl Schumacher17.008.09AE2023-11-14
00842517102736Karl Schumacher17.008.102023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
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08800039000031THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000048THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000055THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000062THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000079THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000086THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000093THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000109THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000116THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000123THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000130THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000147THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15