FDA.reportPublic FDA data

Dental Porous Morsels 2x1.5g

Primary DI
00813909010335
Brand
Dental Porous Morsels 2x1.5g
Company
NOVABONE PRODUCTS, LLC
Model
EU0822
Catalog number
EU0822
Device description
Synthetic bone void filler for dental applications
Published
2025-07-17
Public version status
New
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112428000NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC2011-12-16LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813909010335PrimaryGS10
00813909013756Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909010335008139090103358139090103350813909010335
00813909013756008139090137568139090137560813909013756

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
Weight1.5Gram

Regulatory Flags#

DUNS number
828813290
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813909013589Wound MatrixWM0122SPWM0122SP2026-02-17
00813909013596Wound MatrixWM0123SPWM0123SP2026-02-17
00813909013602Wound MatrixWM0133SPWM0133SP2026-02-17
00813909013619Wound MatrixWM0145SPWM0145SP2026-02-17
00813909013657Wound MatrixWM1011SPWM1011SP2026-02-17
00813909013664Wound MatrixWM1022SPWM1022SP2026-02-17
00813909013671Wound MatrixWM1044SPWM1044SP2026-02-17
00813909013695Wound MatrixWM1033SPWM1033SP2026-02-17
00813909012827Wound MatrixWM0122WM01222023-12-01
00813909012834Wound MatrixWM0123WM01232023-12-01
00813909012841Wound MatrixWM0133WM01332023-12-01
00813909012858Wound MatrixWM0145WM01452023-12-01
00813909013985Putty Syringe with Cannula 2.5ccNB6502NB65022026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNB6505NB65052026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNB6510NB65102026-01-28
00813909013961Putty Syringe 2.5ccNB2702CTNB2702CT2026-01-09
00813909013978Putty Syringe 5.0ccNB2705CTNB2705CT2026-01-09
00813909013909Putty 2.5ccNB0602NVNB0602NV2025-12-26
00813909013916Putty 5.0ccNB0605NVNB0605NV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNB1805NVNB1805NV2025-12-26

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Primary DI, Brand, Company table
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