FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASEAL ID
K Number: K101245
·
Decision Sep 17, 2010
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
103
Review Days
136
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
- ULTRASEAL ID
- K Number
- K101245
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- May 4, 2010
- Decision Date
- September 17, 2010
- 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 Ultradent Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261404 | UltraEZ | Apr 30, 2026 | Substantially Equivalent |
| K240743 | Peak Universal Bond | Mar 20, 2024 | Substantially Equivalent |
| K240694 | FORMA Composite (Shade A3D) | Mar 15, 2024 | Substantially Equivalent |
| K221909 | J-Temp | Jul 1, 2022 | Substantially Equivalent |
| K220471 | VALO X, VALO X Accessory Lenses | Feb 22, 2022 | Substantially Equivalent |
| K211905 | UltraCal XS | Oct 13, 2021 | Substantially Equivalent |
| K211237 | UltraTemp Rez II | Jul 13, 2021 | Substantially Equivalent |
| K210550 | VALO Grand Corded and Accessory Lenses | Mar 1, 2021 | Substantially Equivalent |
| K190627 | VALO Grand Corded | Apr 29, 2019 | Substantially Equivalent |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Feb 9, 2018 | Substantially Equivalent |