Collagen Dental Wound Dressings
FDA 510(k) K152600 · Collagen Matrix, Inc.
510(k) numberK152600
Submission
- Device name
- Collagen Dental Wound Dressings
- Applicant
- Collagen Matrix, Inc.
Oakland, NJ, US - Received
- September 11, 2015
- Decision date
- June 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma 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 (K152600) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 286 days after the submission was received.
What is the product code of K152600?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.