FDA Product Code
FDA Product Code NUN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. | 2014-01-10 | Traditional | PDF ↗ |
| K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | Biomet Interpore Cross | 2012-01-20 | Special | PDF ↗ |
| K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. | 2011-08-12 | Traditional | PDF ↗ |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Musculoskeletal Transplant Foundation | 2009-10-02 | Traditional | PDF ↗ |
| K082463 | PROGENIX | Medtronic Sofamor Danek | 2008-11-10 | Traditional | PDF ↗ |
| K081950 | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | 2008-07-18 | Special | PDF ↗ |
| K080462 | PROGENIX DBM PUTTY | Medtronic Sofamor Danek | 2008-05-13 | Traditional | PDF ↗ |
| K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. | 2008-04-30 | Traditional | PDF ↗ |
| K070147 | INTERGRO ORAL | Biomet 3i | 2007-05-14 | Traditional | PDF ↗ |
| K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV | 2006-03-29 | Traditional | PDF ↗ |
| K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV | 2006-03-27 | Traditional | PDF ↗ |
| K051188 | GRAFTON DBM | Osteotech, Inc. | 2006-01-03 | Traditional | PDF ↗ |
| K042707 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K043573 | DYNAGRAFT II DENTAL | Isotis Orthobiologics, Inc. | 2005-07-29 | Traditional | PDF ↗ |
| K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | Musculoskeletal Transplant Foundation | 2005-04-29 | Traditional | PDF ↗ |
Product code NUN · Class II · Dental. Data: openFDA.