Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025
FDA 510(k) K093390 · Depuy Spine, Inc.
510(k) numberK093390
Submission
- Device name
- Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- October 29, 2009
- Decision date
- May 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025 cleared by the FDA?
Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025 (K093390) received a 510(k) decision of Substantially Equivalent on May 25, 2010, 208 days after the submission was received.
What is the product code of K093390?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.