FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHUR GEL 4
K Number: K860855
·
Decision Jun 16, 1986
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
11
Review Days
101
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Basic Information
- Device Name
- SHUR GEL 4
- K Number
- K860855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Columbus Dental Mfg. Co.
- Date Received
- March 7, 1986
- Decision Date
- June 16, 1986
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Columbus Dental Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K880754 | DRI-CLAVE LIQUID KLEENZALL | May 12, 1988 | Substantially Equivalent |
| 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 |
| K830083 | SHUR GEL | Feb 7, 1983 | Substantially Equivalent |