FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENTRA-FIL II
K Number: K840727
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
15
Review Days
52
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Basic Information
- Device Name
- PENTRA-FIL II
- K Number
- K840727
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pentron Corp.
- Date Received
- February 21, 1984
- Decision Date
- April 13, 1984
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Pentron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | Aug 1, 2002 | Substantially Equivalent |
| K874189 | DUAL-CURE RADIOPAQUE | Feb 11, 1988 | Substantially Equivalent |
| K874275 | OPTEC SUPPLEMENTARY KIT | Jan 19, 1988 | Substantially Equivalent |
| K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | Jan 12, 1988 | Substantially Equivalent |
| K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | Nov 16, 1987 | Substantially Equivalent |
| K873878 | #24L SYSTEM | Oct 27, 1987 | Substantially Equivalent |
| K864404 | PENTRON HIGH STRENGTH PORCELAIN | Nov 24, 1986 | Substantially Equivalent |
| K854803 | CHAMELEON BONDING KIT | Mar 4, 1986 | Substantially Equivalent |
| K844057 | C-22 PIT & FISSURE SEALANT | Dec 3, 1984 | Substantially Equivalent |
| K841457 | NUMBER 21 R/R SYSTEM | May 22, 1984 | Substantially Equivalent |