FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Root Apex Locator
K Number: K212178
·
Decision Jul 20, 2022
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
7
Review Days
373
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Basic Information
- Device Name
- Root Apex Locator
- K Number
- K212178
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd.
- Date Received
- July 12, 2021
- Decision Date
- July 20, 2022
- 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.
Apex Locator (FindPex)
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Apex Locator
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Electronic Apex Locator (Alpha Apex I)
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FDA Unclassified
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Apex Locator
FDA 510(k)
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Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
EQ-PEX
FDA 510(k)
FDA Unclassified
·Unknown
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