Collagen Dental Wound Dressings
FDA 510(k) K033729 · Collagen Matrix, Inc.
510(k) numberK033729
Submission
- Device name
- Collagen Dental Wound Dressings
- Applicant
- Collagen Matrix, Inc.
Franklin Lakes, NJ, US - Received
- November 28, 2003
- Decision date
- March 17, 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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| K253883 | Bonalive MaxillofacialLYC · Special | Bonalive , Ltd. | 05/14/2026SE |
| K251818 | Bontree PlusLYC · Traditional | Hudens Bio Co., Ltd. | 03/06/2026SE |
| 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 |
|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | 11/18/2025SE |
| K243071 | Bovine Dermis Collagen Dermal MatrixKGN · Traditional | 12/19/2024SE |
| K242302 | RejuvaKnee Collagen Meniscus ImplantOLC · Traditional | 10/02/2024SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | 05/01/2024SE |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMQV · Traditional | 03/12/2024SE |
| K231942 | Mineral Collagen Composite Bioactive Extra MoldableMQV · Special | 08/02/2023SE |
| K221735 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 12/20/2022SE |
| K213341 | Fibrillar Collagen Wound DressingKGN · Traditional | 05/31/2022SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | 04/02/2021SE |
| K201859 | Porcine Mineral Collagen Composite MoldableNPM · Traditional | 09/11/2020SE |
Questions and answers
When was Collagen Dental Wound Dressings cleared by the FDA?
Collagen Dental Wound Dressings (K033729) received a 510(k) decision of Substantially Equivalent on March 17, 2004, 110 days after the submission was received.
What is the product code of K033729?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.