FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
DIGORA OPTIME (OR DIGORA ONTIME)
K Number: K041050
·
Decision Jun 15, 2004
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
9
Review Days
54
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Basic Information
- Device Name
- DIGORA OPTIME (OR DIGORA ONTIME)
- K Number
- K041050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soredex Palodex Group OY
- Date Received
- April 22, 2004
- Decision Date
- June 15, 2004
- Product Code
- MUH
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by Soredex Palodex Group OY
| K Number | Device Name | ||
|---|---|---|---|
| K110839 | SCANORA 3D | Jun 30, 2011 | Substantially Equivalent |
| K073350 | SCANORA 3D | Dec 19, 2007 | Substantially Equivalent |
| K070304 | DIGORA PCT/DIGIPOD | Mar 27, 2007 | Substantially Equivalent |
| K063459 | CRANEX NOVUS | Dec 26, 2006 | Substantially Equivalent |
| K043307 | CRANEX D | Dec 17, 2004 | Substantially Equivalent |
| K040382 | CRANEX BASEX D OR CRANEX EXCEL D | Jul 13, 2004 | Substantially Equivalent |
| K033755 | MINRAY | Apr 29, 2004 | Substantially Equivalent |
| K012170 | DIGORA PCT | Aug 10, 2001 | Substantially Equivalent |