FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DMRC Bulk Fill
K Number: K151088
·
Decision Aug 28, 2015
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
127
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
- DMRC Bulk Fill
- K Number
- K151088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Danville Materials, LLC
- Date Received
- April 23, 2015
- Decision Date
- August 28, 2015
- 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 Danville Materials, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K152349 | Star+ VPS Scannable Impression Material | Nov 23, 2015 | Substantially Equivalent |
| K151514 | Prestige | Sep 21, 2015 | Substantially Equivalent |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Mar 18, 2015 | Substantially Equivalent |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Feb 13, 2015 | Substantially Equivalent |