FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFIMED DENTAL SYSTEM
K Number: K962422
·
Decision Sep 11, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
14
Review Days
444
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Basic Information
- Device Name
- INFIMED DENTAL SYSTEM
- K Number
- K962422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infimed, Inc.
- Date Received
- June 24, 1996
- Decision Date
- September 11, 1997
- 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 Infimed, Inc.
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|---|---|---|---|
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| K101833 | INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | Jul 23, 2010 | Substantially Equivalent |
| K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | Mar 16, 2010 | Substantially Equivalent |
| K012490 | ORION DIGITAL IMAGING SYSTEM | Feb 12, 2002 | Substantially Equivalent |
| K992392 | RTLX | Mar 31, 2000 | Substantially Equivalent |
| K992794 | STINGRAY DR, MODEL 1 | Nov 9, 1999 | Substantially Equivalent |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | Oct 7, 1999 | Substantially Equivalent |
| K963037 | PATRIOT | Sep 27, 1996 | Substantially Equivalent |