Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250
FDA 510(k) K993610 · Osteogenics Biomedical, Inc.
510(k) numberK993610
Submission
- Device name
- Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250
- Applicant
- Osteogenics Biomedical, Inc.
Fort Worth, TX, US - Received
- October 25, 1999
- Decision date
- March 2, 2000
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional | 01/23/2021SE |
| K171774 | RPM Reinforced PTFE MeshNPK · Traditional | 10/19/2017SE |
| K093719 | Pro-Fix Precision Fixation System Model Pfm#, Pfb#, Pft#DZL · Traditional | 03/01/2010SE |
| K072076 | Cytoplast PTFE SutureNBY · Abbreviated | 10/31/2007SE |
| K013764 | Immix Bone Graft ExtenderKKY · Traditional | 05/16/2002SE |
| K003028 | Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HCNBY · Traditional | 11/24/2000SE |
| K984230 | Osteo-Mesh TM-300JEY · Traditional | 02/04/1999SE |
Questions and answers
When was Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250 cleared by the FDA?
Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250 (K993610) received a 510(k) decision of Substantially Equivalent on March 2, 2000, 129 days after the submission was received.
What is the product code of K993610?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.