FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SATIN CAST ECONOCAST
K Number: K833287
·
Decision Jan 3, 1984
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
18
Applicant Total
17
Review Days
103
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Basic Information
- Device Name
- SATIN CAST ECONOCAST
- K Number
- K833287
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Genesis Industries, Inc.
- Date Received
- September 22, 1983
- Decision Date
- January 3, 1984
- Product Code
- EIS
- 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 |
|---|---|---|---|
| EIS | Remover, Crown | FDA class 1 | Dental |
Similar 510(k) Clearances
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ATD AUTOMATIC BRIDGE REMOVER
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EASY PNEUMATIC CROWN AND BRIDGE REMOVER
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STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
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HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
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H-TYPE BRIDGE REMOVER
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C & B 40 PENTRO C & B40
FDA 510(k)
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Other Clearances by Genesis Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL | Feb 18, 2000 | Substantially Equivalent |
| K962828 | EVERT-IT | Feb 10, 1997 | Substantially Equivalent |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | Apr 4, 1988 | Substantially Equivalent |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Feb 16, 1988 | Substantially Equivalent |
| K833290 | C & B 40 PENTRO C & B40 | Jan 3, 1984 | Substantially Equivalent |
| K833278 | C & B 45 | Dec 29, 1983 | Substantially Equivalent |
| K833289 | C & B 61 PENTRON C & B61 | Dec 29, 1983 | Substantially Equivalent |
| K833280 | SUPRA AP CHOICE 83 | Dec 26, 1983 | Substantially Equivalent |
| K833285 | RX IV PENTRON IV | Dec 22, 1983 | Substantially Equivalent |
| K833288 | C & B57 PENTRON C & B57 | Dec 20, 1983 | Substantially Equivalent |