FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEAUTISEALANT
K Number: K111782
·
Decision Sep 16, 2011
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
38
Review Days
84
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
- BEAUTISEALANT
- K Number
- K111782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shofu Dental Corporation
- Date Received
- June 24, 2011
- Decision Date
- September 16, 2011
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Shofu Dental Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252808 | GlasIonomer FX-LC | Dec 9, 2025 | Substantially Equivalent |
| K252165 | ZIRCONOMER P | Oct 28, 2025 | Substantially Equivalent |
| K251470 | ResiCem EX | Jul 11, 2025 | Substantially Equivalent |
| K251578 | BEAUTIFIL II | May 27, 2025 | Substantially Equivalent |
| K233161 | BeautiLink SA | Sep 28, 2023 | Substantially Equivalent |
| K222253 | GlasIonomer FX ULTRA | Sep 22, 2022 | Substantially Equivalent |
| K213965 | BeautiBond Xtreme | Mar 18, 2022 | Substantially Equivalent |
| K212939 | Vintage Prime Press | Mar 18, 2022 | Substantially Equivalent |
| K200470 | Shofu Block HC Hard | Feb 5, 2021 | Substantially Equivalent |
| K191794 | Vintage Art Universal | Oct 3, 2019 | Substantially Equivalent |