FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ASEPTICO ENDOPEX V, MODEL AEU-40
K Number: K030895
·
Decision Dec 3, 2003
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
18
Review Days
257
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
- ASEPTICO ENDOPEX V, MODEL AEU-40
- K Number
- K030895
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aseptico, Inc.
- Date Received
- March 21, 2003
- Decision Date
- December 3, 2003
- 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
Other Clearances by Aseptico, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | May 28, 2015 | Substantially Equivalent |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Dec 31, 2014 | Substantially Equivalent |
| K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | Aug 14, 2013 | Substantially Equivalent |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Jun 14, 2011 | Substantially Equivalent |
| K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | Apr 11, 2011 | Substantially Equivalent |
| K103399 | GENERAL DENISTRY MOTOR | Feb 28, 2011 | Substantially Equivalent |
| K070866 | ASC-12 PIEZOELECTRIC SCALER | Apr 11, 2007 | Substantially Equivalent |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | May 3, 2005 | Substantially Equivalent |
| K050201 | AEU-14CF EXPENDITION | Mar 18, 2005 | Substantially Equivalent |
| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Mar 3, 2003 | Substantially Equivalent |