Novabone-Bbg-Resorbable Bone Graft Substitute
FDA 510(k) K033994 · Novabone Products, LLC
510(k) numberK033994
Submission
- Device name
- Novabone-Bbg-Resorbable Bone Graft Substitute
- Applicant
- Novabone Products, LLC
Alachua, FL, US - Received
- December 24, 2003
- Decision date
- March 25, 2004
- 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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| 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 |
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Questions and answers
When was Novabone-Bbg-Resorbable Bone Graft Substitute cleared by the FDA?
Novabone-Bbg-Resorbable Bone Graft Substitute (K033994) received a 510(k) decision of Substantially Equivalent on March 25, 2004, 92 days after the submission was received.
What is the product code of K033994?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.