FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
K Number: K240660
·
Decision Sep 17, 2024
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
7
Review Days
193
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Basic Information
- Device Name
- Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
- K Number
- K240660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kulzer, LLC
- Date Received
- March 8, 2024
- Decision Date
- September 17, 2024
- 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 |
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Other Clearances by Kulzer, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Mar 11, 2026 | Substantially Equivalent |
| K254063 | iCEM Universal Plus | Dec 19, 2025 | Substantially Equivalent |
| K243910 | Retraxil | Sep 24, 2025 | Substantially Equivalent |
| K233868 | dima Print Teeth & Temp | May 23, 2024 | Substantially Equivalent |
| K230644 | Signum opaque F | Sep 7, 2023 | Substantially Equivalent |
| K220605 | Venus Bulk Flow ONE | Apr 21, 2022 | Substantially Equivalent |