FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACQUASEAL BENZ
K Number: K070289
·
Decision May 4, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
1
Review Days
94
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
- ACQUASEAL BENZ
- K Number
- K070289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acquamed Technologies, Inc.
- Date Received
- January 30, 2007
- Decision Date
- May 4, 2007
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBH), ordered by most recent decision date.
Fluoride Varnish (Type A,Type C)
FDA 510(k)
FDA Class 2
·Dental
VOCO Profluorid Varnish + BioMin
FDA 510(k)
FDA Class 2
·Dental
UltraEZ
FDA 510(k)
FDA Class 2
·Dental
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
FDA 510(k)
FDA Class 2
·Dental
FluoroDose Varnish
FDA 510(k)
FDA Class 2
·Dental
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
FDA 510(k)
FDA Class 2
·Dental