3I Calcium Sulfate Bone Cement
FDA 510(k) K012047 · Implant Innovations, Inc.
510(k) numberK012047
Submission
- Device name
- 3I Calcium Sulfate Bone Cement
- Applicant
- Implant Innovations, Inc.
Warsaw, IN, US - Received
- June 29, 2001
- Decision date
- September 19, 2001
- 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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| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
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| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
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More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K062636 | Osseotite, Osseotite Ny, Certain, Certain NT, Prevail, Certain Prevail, XP…DZE · Traditional | 06/01/2007SE |
| K063341 | 3I Osseotite Certain Dental ImplantsDZE · Traditional | 04/30/2007SE |
| K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteDZE · Traditional | 04/24/2007SE |
| K063403 | Conical Angled AbutmentNHA · Traditional | 03/20/2007SE |
| K061629 | Certain Prevail Dental ImplantDZE · Special | 02/23/2007SE |
| K062432 | Nanotite Dental ImplantsDZE · Traditional | 02/22/2007SE |
| K061969 | Preformance Posts and Temporary CylindersNHA · Special | 07/21/2006SE |
| K061177 | Provide Temporary CylinderNHA · Special | 05/16/2006SE |
| K060291 | Preformance Temporary CylinderNHA · Special | 02/27/2006SE |
| K053170 | Preformance PostsNHA · Traditional | 02/01/2006SE |
Questions and answers
When was 3I Calcium Sulfate Bone Cement cleared by the FDA?
3I Calcium Sulfate Bone Cement (K012047) received a 510(k) decision of Substantially Equivalent on September 19, 2001, 82 days after the submission was received.
What is the product code of K012047?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.