FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Porcine Mineral Collagen Composite Moldable
K Number: K201859
·
Decision Sep 11, 2020
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
47
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Porcine Mineral Collagen Composite Moldable
- K Number
- K201859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collagen Matrix, Inc.
- Date Received
- July 6, 2020
- Decision Date
- September 11, 2020
- Product Code
- NPM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPM), ordered by most recent decision date.
BOSS
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
FDA 510(k)
FDA Class 2
·Dental
SwissGraft X
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Flow®
FDA 510(k)
FDA Class 2
·Dental
Xenograft Bovine Bone Particulate
FDA 510(k)
FDA Class 2
·Dental
THE Graft Collagen
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Collagen Matrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Nov 18, 2025 | Substantially Equivalent |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Dec 19, 2024 | Substantially Equivalent |
| K242302 | RejuvaKnee Collagen Meniscus Implant | Oct 2, 2024 | Substantially Equivalent |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | May 1, 2024 | Substantially Equivalent |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Mar 12, 2024 | Substantially Equivalent |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Aug 2, 2023 | Substantially Equivalent |
| K221735 | Mineral Collagen Composite Bioactive Moldable | Dec 20, 2022 | Substantially Equivalent |
| K213341 | Fibrillar Collagen Wound Dressing | May 31, 2022 | Substantially Equivalent |
| K202183 | Porcine Mineral Collagen Composite | Apr 2, 2021 | Substantially Equivalent |
| K182074 | Mineral Collagen Composite Bioactive Moldable | Mar 21, 2019 | Substantially Equivalent |