FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
K Number: K864474
·
Decision Nov 26, 1986
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
13
Review Days
13
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Basic Information
- Device Name
- DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
- K Number
- K864474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Planmeca USA, Inc.
- Date Received
- November 13, 1986
- Decision Date
- November 26, 1986
- 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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|---|---|---|---|
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| K923534 | PM2002 PROLINE | Jan 31, 1994 | Substantially Equivalent |
| K923533 | ADMARK | Mar 4, 1993 | Substantially Equivalent |
| K923462 | DELIGHT | Dec 21, 1992 | Substantially Equivalent |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | Dec 21, 1992 | Substantially Equivalent |
| K904953 | PLANMED SOPHIE | Apr 18, 1991 | Substantially Equivalent |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | Jan 30, 1991 | Substantially Equivalent |
| K904948 | PM2002 CC AND PM2002 EC | Jan 30, 1991 | Substantially Equivalent |
| K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A | Sep 19, 1984 | Substantially Equivalent |