FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ROOT CANAL LENGTH MEASURING DEVICE
K Number: K953867
·
Decision Dec 1, 1995
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
52
Review Days
106
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Basic Information
- Device Name
- ROOT CANAL LENGTH MEASURING DEVICE
- K Number
- K953867
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J. Morita USA, Inc.
- Date Received
- August 17, 1995
- Decision Date
- December 1, 1995
- Product Code
- LQY
- 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQY), ordered by most recent decision date.
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Apex Locator
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Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
Root Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
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