FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRI-CLAVE LIQUID KLEENZALL
K Number: K880754
·
Decision May 12, 1988
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
16
Applicant Total
11
Review Days
77
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Basic Information
- Device Name
- DRI-CLAVE LIQUID KLEENZALL
- K Number
- K880754
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Columbus Dental Mfg. Co.
- Date Received
- February 25, 1988
- Decision Date
- May 12, 1988
- Product Code
- EHZ
- 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 |
|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | FDA class 1 | Dental |
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Other Clearances by Columbus Dental Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K880607 | UTILITY WAX STRIPS, SPEARMINT | Mar 31, 1988 | Substantially Equivalent |
| K880606 | UTILITY WAX STRIPS, CINNAMON | Mar 24, 1988 | Substantially Equivalent |
| K872243 | PEKALUX(TM) | Jul 7, 1987 | Substantially Equivalent |
| K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS | Jul 2, 1987 | Substantially Equivalent |
| K871164 | GLUMA(TM) BONDING SYSTEM | Jul 2, 1987 | Substantially Equivalent |
| K871165 | LUMIFOR(TM) COMPOSITE | Apr 3, 1987 | Substantially Equivalent |
| K863816 | IVORY PREMIUM RUBBER DAM | Oct 27, 1986 | Substantially Equivalent |
| K863758 | ORTHO-BITE WAX WAFER | Oct 7, 1986 | Substantially Equivalent |
| K860855 | SHUR GEL 4 | Jun 16, 1986 | Substantially Equivalent |
| K830083 | SHUR GEL | Feb 7, 1983 | Substantially Equivalent |