REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
FDA 510(k) clearance K080418 · decided 2008-04-30
Clearance details
- K-number
- K080418
- Device name
- REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- Applicant
- Regeneration Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-15
- Decision date
- 2008-04-30
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- NUN
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (K130235) | Hans Biomed Corp. | 2014-01-10 |
| REGENEROSS ALLOGRAFT PLUS MINERLIZED (K113645) | Biomet Interpore Cross | 2012-01-20 |
| EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (K103699) | Exactech, Inc. | 2011-08-12 |
| DBX DEMINERALIZED BONE MATRIX PUTTY (K091217) | Musculoskeletal Transplant Foundation | 2009-10-02 |
| PROGENIX (K082463) | Medtronic Sofamor Danek | 2008-11-10 |
| PROGENIX PLUS (K081950) | Medtronic Sofamor Danek, Inc. | 2008-07-18 |
| PROGENIX DBM PUTTY (K080462) | Medtronic Sofamor Danek | 2008-05-13 |
| INTERGRO ORAL (K070147) | Biomet 3i | 2007-05-14 |
| ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (K060332) | Isotis NV | 2006-03-29 |
| ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (K060306) | Isotis NV | 2006-03-27 |
| GRAFTON DBM (K051188) | Osteotech, Inc. | 2006-01-03 |
| GRAFTON PLUS DBM PASTE (K042707) | Osteotech, Inc. | 2005-11-30 |
Recalls involving this device
No recalls on record reference this clearance.