FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENT CAPS
K Number: K890662
·
Decision May 9, 1989
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
78
Review Days
89
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Basic Information
- Device Name
- PENT CAPS
- K Number
- K890662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Jeneric/Pentron, Inc.
- Date Received
- February 9, 1989
- Decision Date
- May 9, 1989
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
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BENCO ADMIX
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BENCO SPHERICAL
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HIGH SILVER CONVENTIONAL
FDA 510(k)
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Other Clearances by Jeneric/Pentron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020499 | BOND-3 ADHESIVE | Apr 22, 2002 | Substantially Equivalent |
| K013543 | BOND-1 C & B | Feb 22, 2002 | Substantially Equivalent |
| K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | Feb 14, 2002 | Substantially Equivalent |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Aug 23, 2001 | Substantially Equivalent |
| K011748 | FIRST FILL R.C.S. | Aug 3, 2001 | Substantially Equivalent |
| K010957 | QUELL DESENSITIZER | Jun 25, 2001 | Substantially Equivalent |
| K011330 | JP CAST 50 | Jun 22, 2001 | Substantially Equivalent |
| K011331 | JP CAST 40 | Jun 22, 2001 | Substantially Equivalent |
| K011362 | GOLD CORE 73 LS | May 29, 2001 | Substantially Equivalent |
| K010044 | COSMIC | Feb 9, 2001 | Substantially Equivalent |