NOVABONE PRODUCTS, LLC

FDA Device Registration & Listing · ALACHUA, FL, US · Registration 3003768919

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003768919
FEI Number
3003768919
Entity Name
NOVABONE PRODUCTS, LLC
City/State/Country
ALACHUA, FL, US
Establishment Address
13510 NW US Highway 441, ALACHUA, FL 32615, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NOVABONE PRODUCTS, LLC (Owner Number: 9052139)
Owner / Operator Contact Address
13510 NW US Highway 441, Alachua, FL 32615, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080009
PMA Number
N/A

All Registered Proprietary Names

Cartridge Dispenser PerioGlas Bioactive Synthetic Bone Graft Putty Cartridges Bioactive Synthetic Bone Graft Dental Putty Cartridges NovaBone Cartridge Applicator Gun Cartridge Applicator Gun Cartridge Dispenser NovaForm Resorbable Collagen Bioglass Dressing Wound Matrix NovaShield PerioGlas Bioactive Synthetic Bone Graft Particulate Bioactive Strip Oxford: Bioactive Matrix Strip SurMatrix Synthetic Bio Active Strip Resorbable Bioglass Bone Graft Substitute Bioactive Synthetic Bone Graft NovaBone putty trocar cannula Bioactive Synthetic Bone Graft Dental Morsels PerioGlas Bioactive Synthetic Bone Graft Particulate Porous Granules Bioactive Synthetic Bone Graft MIS Cartridge Delivery System MacroFORM Bioactive MIS Composite SurMatrix Synthetic Moldable Composite MacroFORM Bioactive Moldable Composite Bioactive Synthetic Bone Graft Porous Morsels Resorbable Bioglass Bone Graft Substitute BTB - BioActive Bone Graft Putty Bioactive Synthetic Bone Graft Putty Oxford: Bioactive Matrix Bio Putty SurMatrix Synthetic Putty Bioactive Synthetic Bone Graft IRM Bioactive Synthetic Bone Graft MacroPor IRM Oxford: Bioactive Matrix IRM Putty SurMatrix Synthetic Bone Wax Oxford: Bioactive Matrix Bio Putty BTB - BioActive Bone Graft Putty Bioactive Synthetic Bone Graft Putty SurMatrix Synthetic Putty

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2010-12-23
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2017-03-28
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2023-11-28
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2008-01-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2014-11-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-01-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2010-12-23
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2011-12-27
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-08-19
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2014-08-27
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2009-12-15
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2009-12-15
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2017-04-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NOVABONE PRODUCTS, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K052493 Steiner Laboratories SOCKET GRAFT 2006-06-09
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003768919. Last updated year: 2026. Please use registration number 3003768919 when referencing this establishment in official correspondence.
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