Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novabone Products, LLC · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
215 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC | 2024-09-25 | 54 | 0 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6 | Novabone Products, LLC | 2024-03-05 | 25 | 0 |
| K220498 | NovoGen Wound Matrix | Novabone Products, LLC | 2023-06-09 | 472 | 0 |
| K163310 | NovaBone IRM | Novabone Products, LLC | 2017-01-18 | 56 | 0 |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartr | Novabone Products, LLC | 2015-08-26 | 30 | 0 |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | Novabone Products, LLC | 2015-01-08 | 108 | 0 |
| K141207 | NOVABONE BIOACTIVE STRIP | Novabone Products, LLC | 2014-10-31 | 175 | 0 |
| K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BI | Novabone Products, LLC | 2014-08-22 | 130 | 0 |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2011-12-16 | 115 | 0 |
| K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2011-10-14 | 21 | 0 |
| K110925 | NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT | Novabone Products, LLC | 2011-07-05 | 95 | 0 |
| K110368 | NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2011-04-14 | 65 | 0 |
| K101860 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2010-09-01 | 61 | 0 |
| K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2010-03-30 | 21 | 0 |
| K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2009-06-15 | 27 | 0 |
| K090731 | NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD | Novabone Products, LLC | 2009-04-15 | 27 | 0 |
| K082672 | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2008-12-09 | 85 | 0 |
| K080009 | NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT | Novabone Products, LLC | 2008-05-06 | 124 | 0 |
| K063596 | PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL | Novabone Products, LLC | 2007-02-22 | 80 | 0 |
| K063549 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2007-02-12 | 80 | 0 |
| K060728 | NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT | Novabone Products, LLC | 2006-05-01 | 45 | 0 |
| K060432 | NOVABONE POROUS-BONE GRAFT SCAFFOLD | Novabone Products, LLC | 2006-04-04 | 42 | 0 |
| K051617 | NOVABONE PUTTY - RESORBABLE BONE VOID FILLER | Novabone Products, LLC | 2006-03-06 | 262 | 0 |
| K053387 | PERIOGLAS BONE GRAFT PARTICULATE | Novabone Products, LLC | 2006-02-14 | 71 | 0 |
| K052494 | NOVABONE-BIOACTIVE SYNTHETIC GRAFT | Novabone Products, LLC | 2005-11-03 | 52 | 0 |
| K041613 | NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2004-08-25 | 71 | 0 |
| K033994 | NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2004-03-25 | 92 | 0 |
| K040278 | PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2004-03-01 | 25 | 0 |
| K031073 | PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2003-11-05 | 215 | 0 |
| K021336 | NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2002-07-25 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda