FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
BH Medical Dental Barrier Sleeves and Barrier Film
K Number: K190484
·
Decision Sep 10, 2019
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
14
Applicant Total
3
Review Days
195
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
- BH Medical Dental Barrier Sleeves and Barrier Film
- K Number
- K190484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bh Medical Products Co., Ltd.
- Date Received
- February 27, 2019
- Decision Date
- September 10, 2019
- Product Code
- PEM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PEM | Dental Barriers And Sleeves | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEM), ordered by most recent decision date.
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Barrier Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Minitube Dentasleeve Protective Barrier Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery