FDA.reportPublic FDA data

GUIDOR

Primary DI
07640164360140
Brand
GUIDOR
Company
SUNSTAR AMERICAS, INC.
Model
C11-007
Device description
easy-graft CLASSIC Bone grafting material, synthetic
Published
2015-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K131385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131385000EASY-GRAFTDegradable Solutions AG2013-09-27LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640164360140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640164360140076401643601407640164360140

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
Total Volume0.4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure41 Degrees Fahrenheit77 Degrees Fahrenheit
Handling Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Atmospheric Pressure41 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002658353xx@xx.xx

Regulatory Flags#

DUNS number
025066358
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA2025-11-04
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15
00070942007412GUM Technique Sensitive Clean527TRA22025-08-15
00070942008099GUM Technique Sensitive Clean527CNL2025-08-15
10070942007365GUM Technique Sensitive Clean527TPA12025-08-15
10070942007419GUM Technique Sensitive Clean527TRA22025-08-15
20070942008093GUM Technique Sensitive Clean527CNL2025-08-15
00070942008112GUM Technique Deep Clean5255252025-05-19
00070942006378GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
00070942008105GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942006372GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
20070942008109GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942008116GUM Technique Deep Clean5255252025-05-19
00070942006255GUM®625RQ2022-11-10
00070942002783GUM®228RQT2022-11-10

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