FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ODONTOSON 3
K Number: K782133
·
Decision Feb 27, 1979
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
22
Review Days
62
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Basic Information
- Device Name
- ODONTOSON 3
- K Number
- K782133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Mdt Corp., Inc.
- Date Received
- December 27, 1978
- Decision Date
- February 27, 1979
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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Other Clearances by Mdt Corp., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR | May 23, 1996 | Substantially Equivalent |
| K942485 | MDT UROLOGY TABLE | Aug 26, 1994 | Substantially Equivalent |
| K942486 | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | Aug 10, 1994 | Substantially Equivalent |
| K924380 | MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE | Feb 16, 1994 | Substantially Equivalent |
| K926081 | DENTAL LIGHT | Jan 26, 1994 | Substantially Equivalent |
| K924955 | MDT/HARVEY MC-8 AND MC-10 | Oct 15, 1993 | Substantially Equivalent |
| K932094 | BOVIE ULTRASONIC SURGICAL ASPIRATOR | Jul 21, 1993 | Substantially Equivalent |
| K931169 | MDT DENTAL CHAIR | May 20, 1993 | Substantially Equivalent |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mar 31, 1993 | Substantially Equivalent |
| K922212 | MDT CASTLE BIOSIGN TEST PACK | Aug 10, 1992 | Substantially Equivalent |