FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENTRON HIGH STRENGTH PORCELAIN
K Number: K864404
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
15
Review Days
14
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Basic Information
- Device Name
- PENTRON HIGH STRENGTH PORCELAIN
- K Number
- K864404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pentron Corp.
- Date Received
- November 10, 1986
- Decision Date
- November 24, 1986
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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Other Clearances by Pentron Corp.
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|---|---|---|---|
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| 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 |
| 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 |
| K841268 | C-17 | May 22, 1984 | Substantially Equivalent |