FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURAFILL FLOW
K Number: K904555
·
Decision Nov 13, 1990
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
31
Review Days
39
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
- DURAFILL FLOW
- K Number
- K904555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kulzer, Inc.
- Date Received
- October 5, 1990
- Decision Date
- November 13, 1990
- 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 Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904928 | PALAVIT GLC | Jun 6, 1991 | Substantially Equivalent |
| K905058 | PALAVIT L | Jun 6, 1991 | Substantially Equivalent |
| K910263 | CHARISMA | Jun 3, 1991 | Substantially Equivalent |
| K910719 | SILICOATER MD | Apr 29, 1991 | Substantially Equivalent |
| K905131 | DURAFILL COLOR VS | Mar 15, 1991 | Substantially Equivalent |
| K905302 | DENTHESIVE | Feb 26, 1991 | Substantially Equivalent |
| K903317 | DENTALON PLUS | Aug 13, 1990 | Substantially Equivalent |
| K902115 | PALAPRESS(R) VARIO RESIN | Jul 27, 1990 | Substantially Equivalent |
| K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Jul 26, 1990 | Substantially Equivalent |
| K901789 | PALADON(R) 65 | Jun 22, 1990 | Substantially Equivalent |