FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENEW LS-1
K Number: K003317
·
Decision Nov 21, 2000
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
88
Review Days
28
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
- RENEW LS-1
- K Number
- K003317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bisco, Inc.
- Date Received
- October 24, 2000
- Decision Date
- November 21, 2000
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
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 |