FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPHEREX E.C.T.
K Number: K822951
·
Decision Oct 26, 1982
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
25
Review Days
22
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Basic Information
- Device Name
- SPHEREX E.C.T.
- K Number
- K822951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Jeneric Ind.
- Date Received
- October 4, 1982
- Decision Date
- October 26, 1982
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
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BENCO ADMIX
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BENCO SPHERICAL
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HIGH SILVER CONVENTIONAL
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| K840563 | RX C & B 20 | May 1, 1984 | Substantially Equivalent |
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| K834560 | VITEX P.D.A | Feb 27, 1984 | Substantially Equivalent |
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