Bond Bone
FDA 510(k) K101014 · Mis Implants Technologies , Ltd.
510(k) numberK101014
Submission
- Device name
- Bond Bone
- Applicant
- Mis Implants Technologies , Ltd.
Bar Lev Industrial Park, IL - Received
- April 12, 2010
- Decision date
- October 21, 2010
- 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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Questions and answers
When was Bond Bone cleared by the FDA?
Bond Bone (K101014) received a 510(k) decision of Substantially Equivalent on October 21, 2010, 192 days after the submission was received.
What is the product code of K101014?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.