FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
TCM ENDO 20
K Number: K081191
·
Decision Aug 7, 2008
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
11
Review Days
101
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Basic Information
- Device Name
- TCM ENDO 20
- K Number
- K081191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOUVAG AG
- Date Received
- April 28, 2008
- Decision Date
- August 7, 2008
- 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 NOUVAG AG
| K Number | Device Name | ||
|---|---|---|---|
| K080365 | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | Jun 29, 2009 | Substantially Equivalent |
| K071588 | DISPENSER DP 20 | Nov 26, 2007 | Substantially Equivalent |
| K042822 | TCM ENDO V, MODEL 1534 | Dec 22, 2004 | Substantially Equivalent |
| K042943 | NOUVAG AG - VACUSON 40 AND VACUSON 60 | Dec 17, 2004 | Substantially Equivalent |
| K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | Nov 3, 2004 | Substantially Equivalent |
| K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | Oct 1, 2003 | Substantially Equivalent |
| K013185 | TCM ENDO III | Nov 28, 2001 | Substantially Equivalent |
| K000710 | MD 10, SEM, SM 12, CBM | May 11, 2000 | Substantially Equivalent |
| K981679 | TCM 3000 AND TCM ENDO | Feb 9, 1999 | Substantially Equivalent |
| K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 | Jan 16, 1996 | Substantially Equivalent |