Blue Sky Bio TCP
FDA 510(k) K110198 · Blue Sky Bio, LLC
510(k) numberK110198
Submission
- Device name
- Blue Sky Bio TCP
- Applicant
- Blue Sky Bio, LLC
Grayslake, IL, US - Received
- January 24, 2011
- Decision date
- December 22, 2011
- 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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| K190491 | Blue Sky Bio Zygomatic Implant SystemNHA · Traditional | 08/12/2019SE |
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| K180107 | Blue Sky Bio AlignerNXC · Traditional | 02/09/2018SE |
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Questions and answers
When was Blue Sky Bio TCP cleared by the FDA?
Blue Sky Bio TCP (K110198) received a 510(k) decision of Substantially Equivalent on December 22, 2011, 332 days after the submission was received.
What is the product code of K110198?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.