NUN · Bone Grafting Material, Human Source
Dental · 21 CFR 872.3930 · Class 2
Overview
| Product Code | NUN |
|---|---|
| Device Name | Bone Grafting Material, Human Source |
| Regulation | 21 CFR 872.3930 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Classification Rationale
(1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.) (2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. | Jan 10, 2014 | SESE |
| K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | Biomet Interpore Cross | Jan 20, 2012 | SESE |
| K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. | Aug 12, 2011 | SESE |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Musculoskeletal Transplant Foundation | Oct 2, 2009 | SESE |
| K082463 | PROGENIX | Medtronic Sofamor Danek | Nov 10, 2008 | SESE |
| K081950 | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | Jul 18, 2008 | SESE |
| K080462 | PROGENIX DBM PUTTY | Medtronic Sofamor Danek | May 13, 2008 | SESE |
| K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. | Apr 30, 2008 | SESE |
| K070147 | INTERGRO ORAL | Biomet 3i | May 14, 2007 | SESE |
| K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV | Mar 29, 2006 | SESE |
| K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV | Mar 27, 2006 | SESE |
| K051188 | GRAFTON DBM | Osteotech, Inc. | Jan 3, 2006 | SESE |
| K042707 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | Nov 30, 2005 | SESE |
| K043573 | DYNAGRAFT II DENTAL | Isotis Orthobiologics, Inc. | Jul 29, 2005 | SESE |
| K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | Musculoskeletal Transplant Foundation | Apr 29, 2005 | SESE |
Top Applicants
- Isotis NV — 2 clearances
- Medtronic Sofamor Danek — 2 clearances
- Musculoskeletal Transplant Foundation — 2 clearances
- Osteotech, Inc. — 2 clearances
- Biomet 3i — 1 clearance
