FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DenMat Bulk Fill Composite
K Number: K242097
·
Decision Oct 15, 2024
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- DenMat Bulk Fill Composite
- K Number
- K242097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Den-Mat Holdings, LLC
- Date Received
- July 18, 2024
- Decision Date
- October 15, 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 Den-Mat Holdings, LLC
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|---|---|---|---|
| K162967 | nuance UNIVERSAL | Mar 24, 2017 | Substantially Equivalent |
| K143679 | Nuance FLOW | May 1, 2015 | Substantially Equivalent |
| K140537 | TENURE4G | Aug 20, 2014 | Substantially Equivalent |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | Feb 10, 2011 | Substantially Equivalent |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | Dec 29, 2010 | Substantially Equivalent |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | Nov 21, 2008 | Substantially Equivalent |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Apr 3, 2008 | Substantially Equivalent |