FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMREX-DENTIN VARNISH
K Number: K851030
·
Decision Jun 20, 1985
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
2
Review Days
100
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Basic Information
- Device Name
- TEMREX-DENTIN VARNISH
- K Number
- K851030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Temrex Corp.
- Date Received
- March 12, 1985
- Decision Date
- June 20, 1985
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
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Other Clearances by Temrex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) | Dec 7, 2012 | Substantially Equivalent |