FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UTILITY WAX STRIPS, CINNAMON
K Number: K880606
·
Decision Mar 24, 1988
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
11
Review Days
41
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
- UTILITY WAX STRIPS, CINNAMON
- K Number
- K880606
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Columbus Dental Mfg. Co.
- Date Received
- February 12, 1988
- Decision Date
- March 24, 1988
- Product Code
- EGD
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGD), ordered by most recent decision date.
BRACE EZE
FDA 510(k)
FDA Class 1
·Dental
GLENROE ORTHO-SIL
FDA 510(k)
FDA Class 1
·Dental
ORTHO WAX
FDA 510(k)
FDA Class 1
·Dental
BURNOUT MATERIAL
FDA 510(k)
FDA Class 1
·Dental
SALIVA-STIM
FDA 510(k)
FDA Class 1
·Dental
BITE RIM WAX
FDA 510(k)
FDA Class 1
·Dental
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 |
| 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 |