FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K Number: K142124
·
Decision Dec 31, 2014
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
18
Review Days
149
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Basic Information
- Device Name
- AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
- K Number
- K142124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aseptico, Inc.
- Date Received
- August 4, 2014
- Decision Date
- December 31, 2014
- Product Code
- EKX
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
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Other Clearances by Aseptico, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | May 28, 2015 | 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 |
| K030895 | ASEPTICO ENDOPEX V, MODEL AEU-40 | Dec 3, 2003 | Substantially Equivalent |
| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Mar 3, 2003 | Substantially Equivalent |