Carrigen
FDA 510(k) K100883 · Etex Corp.
510(k) numberK100883
Submission
- Device name
- Carrigen
- Applicant
- Etex Corp.
Cambridge, MA, US - Received
- March 30, 2010
- Decision date
- December 21, 2010
- 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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| K244006 | FG Bone Graft MLYC · Traditional | Full Golden Biotech Co., Ltd. | 09/17/2025SE |
| K243745 | FG Bone Graft BLYC · Traditional | Full Golden Biotech Corporation | 08/29/2025SE |
| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
| K202675 | InRoad® Dental Synthetic Bone GraftLYC · Traditional | Osteogene Tech Corp | 03/04/2022SE |
| 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 |
|---|---|---|
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )MQV · Special | 12/18/2024SE |
| K182107 | CarriGen PFMQV · Special | 08/31/2018SE |
| K132868 | CarricellMQV · Traditional | 02/20/2015SE |
| K141245 | Etex Mixing and Delivery SystemFMF · Traditional | 07/09/2014SE |
| K102812 | Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special | 12/03/2010SE |
| K101557 | Gamma-Bsm, Beta-Bsm, Equivabone, CarigenMQV · Special | 07/01/2010SE |
| K093447 | CarrigenMQV · Special | 02/18/2010SE |
| K091729 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional | 12/23/2009SE |
| K091607 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneMQV · Traditional | 11/02/2009SE |
| K090855 | Equivabone Osteoinductive Bone Graft SubstituteMQV · Traditional | 09/18/2009SE |
Questions and answers
When was Carrigen cleared by the FDA?
Carrigen (K100883) received a 510(k) decision of Substantially Equivalent on December 21, 2010, 266 days after the submission was received.
What is the product code of K100883?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.