FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOS DC
K Number: K030634
·
Decision Jul 21, 2003
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
13
Review Days
144
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Basic Information
- Device Name
- ENDOS DC
- K Number
- K030634
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Villa Sistemi Medicali S.P.A.
- Date Received
- February 27, 2003
- Decision Date
- July 21, 2003
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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Other Clearances by Villa Sistemi Medicali S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | Nov 2, 2018 | Substantially Equivalent |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | Jul 6, 2017 | Substantially Equivalent |
| K130109 | ENDOGRAPH DC | Aug 1, 2013 | Substantially Equivalent |
| K111152 | ROTOGRAPH EVO 3D | Jul 22, 2011 | Substantially Equivalent |
| K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | May 18, 2009 | Substantially Equivalent |
| K080859 | DRF 4343 | Jun 4, 2008 | Substantially Equivalent |
| K050190 | APOLLO | Mar 25, 2005 | Substantially Equivalent |
| K030185 | ENDOS AC/ACP | Mar 11, 2003 | Substantially Equivalent |
| K002432 | STRATO X | Sep 1, 2000 | Substantially Equivalent |
| K000412 | VISION R/F TILTING TABLE | Apr 24, 2000 | Substantially Equivalent |