Osteon III
FDA 510(k) K153676 · Genoss Co., Ltd.
510(k) numberK153676
Submission
- Device name
- Osteon III
- Applicant
- Genoss Co., Ltd.
Suwon-Si, KR - Received
- December 21, 2015
- Decision date
- September 14, 2016
- 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 Osteon III cleared by the FDA?
Osteon III (K153676) received a 510(k) decision of Substantially Equivalent on September 14, 2016, 268 days after the submission was received.
What is the product code of K153676?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.