FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
BOMEDENT Apex locator, WISMY Apex locator
K Number: K203836
·
Decision Mar 30, 2021
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
3
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BOMEDENT Apex locator, WISMY Apex locator
- K Number
- K203836
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Bomedent Medical Technology Co.,Ltd
- Date Received
- December 30, 2020
- Decision Date
- March 30, 2021
- 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)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Electronic Apex Locator (Alpha Apex I)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
Root Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown