FDA.reportPublic FDA data

Foundation

Primary DI
20386040015247
Brand
Foundation
Company
Gc America Inc.
Model
27-500-100
Catalog number
27-500-100
Device description
Collagen-Based Bone Filling Augmentation Material
Published
2024-03-12
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

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
20386040015247PackageGS110In Commercial Distribution
00386040015243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038604001524720386040015247
00386040015243003860400152433860400152430386040015243

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
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
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
10386040013437EXA Advanced1381121381122022-08-12
10386040013444EXA Advanced1381131381132022-08-12
10386040013451EXA Advanced1381161381162022-08-12
10386040013468EXA Advanced1381171381172022-08-12
10386040013475EXA Advanced1381181381182022-08-12
10386040013482EXA Advanced1381191381192022-08-12
10386040013871EQUIA®4520034520032022-07-13
D6581200011COE ALGINATE™1200011200012016-08-01
D6581201011COE ALGINATE™1201011201012016-08-01
D6581210011COE ALGINATE™1210011210012016-08-01
D6581211011COE ALGINATE™1211011211012016-08-01
D6581240011COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241011COE HYDROPHILIC GEL™1241011241012016-08-01
D6581310021COE-FLEX®1310021310022016-08-01
D6581310031COE-FLEX®1310031310032016-08-01
D6581310041COE-FLEX®1310041310042016-08-01

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