Straumann Granules
FDA 510(k) K040646 · The Straumann Co.
510(k) numberK040646
Submission
- Device name
- Straumann Granules
- Applicant
- The Straumann Co.
Waltham, MA, US - Received
- March 11, 2004
- Decision date
- May 3, 2004
- 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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| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | Institut Straumann AG | 09/24/2020SE |
More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K041070 | Straumann Temporary CopingNHA · Traditional | 07/23/2004SE |
| K040469 | The Straumann Ortho Implant SystemOAT · Traditional | 04/30/2004SE |
| K993862 | Modus Sagittal Split PlateJEY · Traditional | 12/29/1999SE |
| K962023 | Plastic Protection Healing CapsDZE · Traditional | 08/15/1996SE |
| K960634 | Titanium Healing CapsDZE · Traditional | 06/18/1996SE |
| K955281 | Endosseous Dental Implant & AccessoriesDZE · Traditional | 03/15/1996SE |
| K955369 | MemfixDZL · Traditional | 01/23/1996SE |
| K941393 | Iti Angled AbutmentDZE · Traditional | 06/14/1995SE |
| K943720 | Iti Transversal Screwing SystemDZE · Traditional | 03/24/1995SE |
| K931993 | Iti Distance SystemDZE · Traditional | 04/26/1994SE |
Questions and answers
When was Straumann Granules cleared by the FDA?
Straumann Granules (K040646) received a 510(k) decision of Substantially Equivalent on May 3, 2004, 53 days after the submission was received.
What is the product code of K040646?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.