FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-CARE
K Number: K770997
·
Decision Jun 20, 1977
Classifications
1
FEI Numbers
343
Registration Numbers
344
Same Product Code
53
Applicant Total
16
Review Days
19
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Basic Information
- Device Name
- PRO-CARE
- K Number
- K770997
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6865
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Date Received
- June 1, 1977
- Decision Date
- June 20, 1977
- Product Code
- JEQ
- 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 |
|---|---|---|---|
| JEQ | Toothbrush, Powered | FDA class 1 | Dental |
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| K875340 | JETPOLISHER(TM) | Jun 10, 1988 | Substantially Equivalent |
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| K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | Jun 9, 1982 | Substantially Equivalent |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Jun 15, 1979 | Substantially Equivalent |