FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
K Number: K992919
·
Decision Nov 19, 1999
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
40
Applicant Total
2
Review Days
81
Basic Information
- Device Name
- OXY-GLIDE ROOT CANAL CLEANSER & LUB.
- K Number
- K992919
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUPER GLIDE, INC.
- Date Received
- August 30, 1999
- Decision Date
- November 19, 1999
- Product Code
- KJJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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Other Clearances by SUPER GLIDE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K003422 | EDTA ROOT CANAL CLEANSER | Jan 19, 2001 | Substantially Equivalent |