Manufacturer registered with FDA
Novabone Products, LLC
Alachua, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 92003–2011
- Markets registered in
- 15113 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Novabone Products, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Novabone Products, LLC | 9 clearances | 2003–2011 | Below |
| European Union | EUDAMED | Manufacturer | NovaBone Products, LLC | 32 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NOVABONE PRODUCTS; LLCNovaBone Products, LLC | 21 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | NOVABONE PRODUCTS LLC | 17 | 1999–2016 | Pure Global AI |
| Colombia | INVIMA | Registration holder | NOVABONE PRODUCTS LLC | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NOVABONE PRODUCTS, LLCNOVABONE PRODUCTS,LLC | 8 | 2012–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Novabone Products LLC | 6 | 2015–2018 | Pure Global AI |
| China | NMPA | Registration holder | 美国诺邦生物制品有限公司NovaBone Products, LLC | 4 | — | Pure Global AI |
| India | CDSCO | Registration holder | NovaBone Products Pvt. Ltd. | 3 | 2018–2018 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NOVABONE PRODUCTS, LLC. | 3 | 2018–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NovaBone Products, LLCNOVABONE PRODUCTS, LLC. | 3 | 2008–2016 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | NovaBone Products, LLC | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | NovaBone Products LLCNovaBone Products, LLC | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | NovaBone Products LLC | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | NovaBone Products, LLC | 1 | 2008–2008 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Novabone Products, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Bioactive Synthetic Bone Graft Dental MorselsBioactive Synthetic Bone Graft Dental Putty CartridgesCartridge DispenserNovaBone Cartridge Applicator GunPerioGlas Bioactive Synthetic Bone Graft ParticulatePerioGlas Bioactive Synthetic Bone Graft Putty CartridgesPorous Granules Bioactive Synthetic Bone Graft | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Cartridge Applicator GunCartridge Dispenser | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Novabone Products, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Dec 2011 | K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | LYC Synthetic Bone Grafting Material |
| 30 Mar 2010 | K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | LYC Synthetic Bone Grafting Material |
| 15 Jun 2009 | K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | LYC Synthetic Bone Grafting Material |
| 22 Feb 2007 | K063596 | PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL | LYC Synthetic Bone Grafting Material |
| 12 Feb 2007 | K063549 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | LYC Synthetic Bone Grafting Material |
| 14 Feb 2006 | K053387 | PERIOGLAS BONE GRAFT PARTICULATE | LYC Synthetic Bone Grafting Material |
| 25 Mar 2004 | K033994 | NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE | LYC Synthetic Bone Grafting Material |
| 1 Mar 2004 | K040278 | PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE | LYC Synthetic Bone Grafting Material |
| 5 Nov 2003 | K031073 | PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NOVABONE PRODUCTS, LLCFDA reg. 3003768919 | ALACHUA, FL, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052139). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.