Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) → NUN — Bone Grafting Material, Human Source # NUN · Bone Grafting Material, Human Source _Dental · 21 CFR 872.3930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN ## Overview - **Product Code:** NUN - **Device Name:** Bone Grafting Material, Human Source - **Regulation:** [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K130235.md) | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. | Jan 10, 2014 | SESE | | [K113645](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K113645.md) | REGENEROSS ALLOGRAFT PLUS MINERLIZED | Biomet Interpore Cross | Jan 20, 2012 | SESE | | [K103699](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K103699.md) | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. | Aug 12, 2011 | SESE | | [K091217](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K091217.md) | DBX DEMINERALIZED BONE MATRIX PUTTY | Musculoskeletal Transplant Foundation | Oct 2, 2009 | SESE | | [K082463](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K082463.md) | PROGENIX | Medtronic Sofamor Danek | Nov 10, 2008 | SESE | | [K081950](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K081950.md) | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | Jul 18, 2008 | SESE | | [K080462](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K080462.md) | PROGENIX DBM PUTTY | Medtronic Sofamor Danek | May 13, 2008 | SESE | | [K080418](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K080418.md) | 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K070147.md) | INTERGRO ORAL | Biomet 3i | May 14, 2007 | SESE | | [K060332](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K060332.md) | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV | Mar 29, 2006 | SESE | | [K060306](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K060306.md) | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV | Mar 27, 2006 | SESE | | [K051188](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K051188.md) | GRAFTON DBM | Osteotech, Inc. | Jan 3, 2006 | SESE | | [K042707](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K042707.md) | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | Nov 30, 2005 | SESE | | [K043573](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K043573.md) | DYNAGRAFT II DENTAL | Isotis Orthobiologics, Inc. | Jul 29, 2005 | SESE | | [K040501](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K040501.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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