FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHROMA ZONE COLOR STAIN
K Number: K982259
·
Decision Sep 22, 1998
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
11
Review Days
88
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
- CHROMA ZONE COLOR STAIN
- K Number
- K982259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray America, Inc.
- Date Received
- June 26, 1998
- Decision Date
- September 22, 1998
- 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 Kuraray America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111982 | CLEARFIL DC CORE PLUS | Nov 17, 2011 | Substantially Equivalent |
| K111980 | CLEARFIL TRI-S BOND PLUS | Oct 14, 2011 | Substantially Equivalent |
| K063595 | CLEARFIL MAJESTY POSTERIOR | Feb 9, 2007 | Substantially Equivalent |
| K063593 | CLEARFIL MAJESTY FLOW | Feb 2, 2007 | Substantially Equivalent |
| K063228 | SURFACE COAT | Dec 8, 2006 | Substantially Equivalent |
| K002322 | MODIFICATION TO PANAVIA F | Sep 18, 2000 | Substantially Equivalent |
| K983361 | PANAVIA F | Nov 13, 1998 | Substantially Equivalent |
| K982164 | ESTENIA | Aug 10, 1998 | Substantially Equivalent |
| K974486 | CLEARFIL LINER BOND 2V | Jan 29, 1998 | Substantially Equivalent |
| K974089 | ALLOY PRIMER | Dec 17, 1997 | Substantially Equivalent |