FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE BOND SE
K Number: K063780
·
Decision Jan 19, 2007
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
88
Review Days
29
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
- ACE BOND SE
- K Number
- K063780
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bisco, Inc.
- Date Received
- December 21, 2006
- Decision Date
- January 19, 2007
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Bisco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250156 | Choice 2 DC | Jul 11, 2025 | Substantially Equivalent |
| K242816 | Quantium | Dec 17, 2024 | Substantially Equivalent |
| K192007 | TheraBase, TheraBase Ca | Mar 17, 2020 | Substantially Equivalent |
| K182917 | FluoroCal | Nov 18, 2019 | Substantially Equivalent |
| K180344 | TheraCal DC | Apr 5, 2018 | Substantially Equivalent |
| K171147 | REVEAL Bulk | Aug 4, 2017 | Substantially Equivalent |
| K162598 | HAPI Seal | May 23, 2017 | Substantially Equivalent |
| K163171 | CeraClean | Apr 14, 2017 | Substantially Equivalent |
| K161051 | All-Bond Universal w/BAC (not finalized) | Sep 9, 2016 | Substantially Equivalent |
| K161256 | TheraCem | Jul 29, 2016 | Substantially Equivalent |