Perioglas Putty-Bioactive Bone Graft Gel
FDA 510(k) K063596 · Novabone Products, LLC
510(k) numberK063596
Submission
- Device name
- Perioglas Putty-Bioactive Bone Graft Gel
- Applicant
- Novabone Products, LLC
Alachua, FL, US - Received
- December 4, 2006
- Decision date
- February 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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| 510(k) | Device | Decision |
|---|---|---|
| K242299 | NovaBone Putty - Synthetic Bioactive Bone GraftMQV · Traditional | 09/25/2024SE |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)MQV · Special | 03/05/2024SE |
| K220498 | NovoGen Wound MatrixKGN · Traditional | 06/09/2023SE |
| K163310 | NovaBone IRMMQV · Traditional | 01/18/2017SE |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…MQV · Special | 08/26/2015SE |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug)KGN · Traditional | 01/08/2015SE |
| K141207 | Novabone Bioactive StripMQV · Traditional | 10/31/2014SE |
| K140946 | Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeMQV · Traditional | 08/22/2014SE |
| K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone GraftLYC · Traditional | 12/16/2011SE |
| K112773 | Novabne Putty Bioactive Synthetic Bone GraftMQV · Special | 10/14/2011SE |
Questions and answers
When was Perioglas Putty-Bioactive Bone Graft Gel cleared by the FDA?
Perioglas Putty-Bioactive Bone Graft Gel (K063596) received a 510(k) decision of Substantially Equivalent on February 22, 2007, 80 days after the submission was received.
What is the product code of K063596?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.