FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C & B 61 PENTRON C & B61
K Number: K833289
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
18
Applicant Total
17
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- C & B 61 PENTRON C & B61
- K Number
- K833289
- 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
- December 29, 1983
- 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
Other 510(k) clearances with the same product code (EIS), ordered by most recent decision date.
ATD AUTOMATIC BRIDGE REMOVER
FDA 510(k)
FDA Class 1
·Dental
EASY PNEUMATIC CROWN AND BRIDGE REMOVER
FDA 510(k)
FDA Class 1
·Dental
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
FDA 510(k)
FDA Class 1
·Dental
HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
FDA 510(k)
FDA Class 1
·Dental
H-TYPE BRIDGE REMOVER
FDA 510(k)
FDA Class 1
·Dental
SATIN CAST ECONOCAST
FDA 510(k)
FDA Class 1
·Dental
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 |
| K833287 | SATIN CAST ECONOCAST | Jan 3, 1984 | Substantially Equivalent |
| K833290 | C & B 40 PENTRO C & B40 | Jan 3, 1984 | Substantially Equivalent |
| K833278 | C & B 45 | 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 |