FDA.reportPublic FDA data

Foundation®

Primary DI
14560245656811
Brand
Foundation®
Company
OLYMPUS TERUMO BIOMATERIALS CORP.
Model
27-500-200
Catalog number
27-500-200
Device description
Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of absorbable atelo-collagen. The atelo-collagen has been cro
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111087000FOUNDATIONOlympus Terumo Biomaterials Corporation2011-11-29LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560245656811PackageGS15In Commercial Distribution
04560245656814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456024565681114560245656811
04560245656814045602456568144560245656814

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) 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 used to fill bone cavities and defects and contains pores that 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
Length25Millimeter
Outer Diameter15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-831-3222info@jmoritausa.com

Regulatory Flags#

DUNS number
697730638
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
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560245656814Foundation®27-500-20027-500-2002015-09-24
04560245656821Foundation®27-500-10027-500-1002015-09-24
14560245656828Foundation®27-500-10027-500-1002015-09-24

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
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
08809324764870OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764887OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764894OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764900OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764917OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764924OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764931OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764948OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764955OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764962OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764979OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764986OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764993OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765006OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765013OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765020OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765082OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765105OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765136OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765174OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324768014OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768021OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768038OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768045OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768052OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768069OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768076OsteonIIIGENOSS CO., Ltd.LYC2018-07-10