Bio-Blocks
FDA 510(k) K970569 · Geistlich-Pharma
510(k) numberK970569
Submission
- Device name
- Bio-Blocks
- Applicant
- Geistlich-Pharma
Washington, DC, US - Received
- January 28, 1997
- Decision date
- August 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Bio-Blocks cleared by the FDA?
Bio-Blocks (K970569) received a 510(k) decision of Substantially Equivalent on August 14, 2000, 1,294 days after the submission was received.
What is the product code of K970569?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.