Collagen Dental Menbrane - Conformable II
FDA 510(k) K062881 · Collagen Matrix, Inc.
510(k) numberK062881
Submission
- Device name
- Collagen Dental Menbrane - Conformable II
- Applicant
- Collagen Matrix, Inc.
Franklin Lakes, NJ, US - Received
- September 26, 2006
- Decision date
- October 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPL – Barrier, Animal Source, Intraoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
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More from Sigmagraft, Inc.
| 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 Menbrane - Conformable II cleared by the FDA?
Collagen Dental Menbrane - Conformable II (K062881) received a 510(k) decision of Substantially Equivalent on October 11, 2006, 15 days after the submission was received.
What is the product code of K062881?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.