Cytoplast GBR
FDA 510(k) K964342 · Osteogenics Co.
510(k) numberK964342
Submission
- Device name
- Cytoplast GBR
- Applicant
- Osteogenics Co.
Fort Worth, TX, US - Received
- October 31, 1996
- Decision date
- March 11, 1997
- 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 |
|---|---|---|
| K061934 | XtacFTL · Traditional | 07/17/2007SE |
| K983753 | Star Temporary Wound CoverFTL · Traditional | 11/18/1999SE |
| K972278 | Cytoplast Regentex Titanium 250LYC · Traditional | 08/06/1997SE |
| K964537 | Bonesource Hydroxyapatite Cement (Hac)GXP · Traditional | 01/24/1997SE |
| K953339 | Bonesource Hydroxyapatite Cement (Hac)GXP · Traditional | 06/27/1996SE |
Questions and answers
When was Cytoplast GBR cleared by the FDA?
Cytoplast GBR (K964342) received a 510(k) decision of Substantially Equivalent on March 11, 1997, 131 days after the submission was received.
What is the product code of K964342?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.