FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-Oss
K Number: K151542
·
Decision Aug 3, 2016
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
26
Review Days
422
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
- A-Oss
- K Number
- K151542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hiossen, Inc.
- Date Received
- June 8, 2015
- Decision Date
- August 3, 2016
- 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 Hiossen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | May 14, 2026 | Substantially Equivalent |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Jan 29, 2026 | Substantially Equivalent |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Jan 8, 2025 | Substantially Equivalent |
| K240232 | EK D3.3 and Ultra Wide Implants | Sep 13, 2024 | Substantially Equivalent |
| K233389 | EK Digital Abutments | May 29, 2024 | Substantially Equivalent |
| K222636 | ET Abutment System | Apr 28, 2023 | Substantially Equivalent |
| K203360 | EK Implants and Abutments System | Jan 7, 2022 | Substantially Equivalent |
| K191751 | EM Provisional | Dec 16, 2019 | Substantially Equivalent |
| K191201 | EM SA Implant System | Nov 15, 2019 | Substantially Equivalent |
| K183242 | ET IV SA Dental Implants | May 21, 2019 | Substantially Equivalent |