FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
OSSIX Breeze
K Number: K212509
·
Decision Jul 18, 2022
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
4
Review Days
343
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
- OSSIX Breeze
- K Number
- K212509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datum Dental, Ltd.
- Date Received
- August 9, 2021
- Decision Date
- July 18, 2022
- Product Code
- NPL
- 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPL), ordered by most recent decision date.
Jason membrane
FDA 510(k)
FDA Class 2
·Dental
Augmented Gingival Matrix
FDA 510(k)
FDA Class 2
·Dental
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
FDA 510(k)
FDA Class 2
·Dental
SwissMembrane X; SwissMembrane X Socket
FDA 510(k)
FDA Class 2
·Dental
Soft Tissue Augmentation Resorbable Matrix
FDA 510(k)
FDA Class 2
·Dental