FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOLD CORE 35
K Number: K023501
·
Decision Dec 18, 2002
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
5
Review Days
61
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Basic Information
- Device Name
- GOLD CORE 35
- K Number
- K023501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pentron Laboratory Technologies
- Date Received
- October 18, 2002
- Decision Date
- December 18, 2002
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by Pentron Laboratory Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K023742 | SCULPTURE PLUS NANO-HYBRID COMPOSITE | Jan 17, 2003 | Substantially Equivalent |
| K023499 | GOLD CORE PLUS | Jan 13, 2003 | Substantially Equivalent |
| K023502 | JEWEL CAST PLUS | Dec 18, 2002 | Substantially Equivalent |
| K020555 | SONATA MICRO HYBRID COMPOSITE | Apr 22, 2002 | Substantially Equivalent |