FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RETRACTION PASTE
K Number: K130580
·
Decision Feb 25, 2014
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
28
Review Days
357
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Basic Information
- Device Name
- RETRACTION PASTE
- K Number
- K130580
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmg USA, Inc.
- Date Received
- March 5, 2013
- Decision Date
- February 25, 2014
- Product Code
- MVL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
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|---|---|---|---|
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| 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 |