510(k) K080418
- Device
- REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- Applicant
- REGENERATION TECHNOLOGIES, INC.
- 510(k) number
- K080418
- Product code
- NUN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-30
- Date received
- 2008-02-15
- Regulation
- 872.3930
- Classification name
- Bone Grafting Material, Human Source
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRAVIS AROLA
- Address
- 11621 Research Cir. P.O. Box 2650 Alachua FL US 32616 32616
FDA Registration Numbers#
- 1030489
- 3003828812
- 2249062
- 3011936113
- 1319660
- 3018094310
- 1000244346
- 1225112
- 2528981
- 1000307092
- 2029275
- 3002719998
- 1450662
- 3011276344
- 3004431266
- 1038806
- 3008812241
- 2024024
- 1066741
- 2249915
- 2090010
- 3010097171
- 1038671
- 1054811
Source Documents#
Other 510(k) Records For Product Code NUN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. | 2014-01-10 |
| K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | Biomet Interpore Cross | 2012-01-20 |
| K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. | 2011-08-12 |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Musculoskeletal Transplant Foundation | 2009-10-02 |
| K082463 | PROGENIX | Medtronic Sofamor Danek | 2008-11-10 |
| K081950 | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | 2008-07-18 |
| K080462 | PROGENIX DBM PUTTY | Medtronic Sofamor Danek | 2008-05-13 |
| K070147 | INTERGRO ORAL | Biomet 3i | 2007-05-14 |
| K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV | 2006-03-29 |
| K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV | 2006-03-27 |
| K051188 | GRAFTON DBM | Osteotech, Inc. | 2006-01-03 |
| K042707 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-30 |
| K043573 | DYNAGRAFT II DENTAL | Isotis Orthobiologics, Inc. | 2005-07-29 |
| K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | Musculoskeletal Transplant Foundation | 2005-04-29 |
Legacy Summary#
summary
FDA Review#
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