FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K Number: K952240
·
Decision Aug 18, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
129
Applicant Total
78
Review Days
98
Basic Information
- Device Name
- TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
- K Number
- K952240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- JENERIC/PENTRON, INC.
- Date Received
- May 12, 1995
- Decision Date
- August 18, 1995
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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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 |
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| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Aug 23, 2001 | Substantially Equivalent |
| K011748 | FIRST FILL R.C.S. | Aug 3, 2001 | Substantially Equivalent |
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| K011331 | JP CAST 40 | Jun 22, 2001 | Substantially Equivalent |
| K011330 | JP CAST 50 | Jun 22, 2001 | Substantially Equivalent |
| K011362 | GOLD CORE 73 LS | May 29, 2001 | Substantially Equivalent |
| K010044 | COSMIC | Feb 9, 2001 | Substantially Equivalent |