FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ecosite Bulk Fill
K Number: K171772
·
Decision Jan 31, 2018
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
28
Review Days
231
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Basic Information
- Device Name
- Ecosite Bulk Fill
- K Number
- K171772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmg USA, Inc.
- Date Received
- June 14, 2017
- Decision Date
- January 31, 2018
- 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 Dmg USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160443 | TempoCem Clear | Sep 30, 2016 | Substantially Equivalent |
| K130580 | RETRACTION PASTE | Feb 25, 2014 | Substantially Equivalent |
| K110759 | TEMPOCEM | Jun 10, 2011 | Substantially Equivalent |
| K102603 | SA FLOWABLE ADHESIVE | Nov 17, 2010 | Substantially Equivalent |
| K101710 | LUXATEMP ULTRA /STAR | Sep 28, 2010 | Substantially Equivalent |
| K100062 | INFILTRATION KIT | Mar 26, 2010 | Substantially Equivalent |
| K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Feb 12, 2010 | Substantially Equivalent |
| K093587 | DENTAL MERCURY | Jan 21, 2010 | Substantially Equivalent |
| K081493 | INFILTRATION KIT | Sep 18, 2008 | Substantially Equivalent |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | May 30, 2008 | Substantially Equivalent |