FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
K Number: K103244
·
Decision Feb 14, 2011
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
12
Review Days
104
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Basic Information
- Device Name
- QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
- K Number
- K103244
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Intl., Inc.
- Date Received
- November 2, 2010
- Decision Date
- February 14, 2011
- Product Code
- KJJ
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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