FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTEC LIGHT
K Number: K030641
·
Decision Jun 10, 2003
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
7
Review Days
102
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Basic Information
- Device Name
- CONTEC LIGHT
- K Number
- K030641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentaurum
- Date Received
- February 28, 2003
- Decision Date
- June 10, 2003
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
| K062733 | TOMAS PIN SD 6, 8, AND 10 MM | Nov 9, 2006 | Substantially Equivalent |
| K062732 | TOMAS PIN 6 MM | Oct 25, 2006 | Substantially Equivalent |
| K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | Nov 21, 2003 | Substantially Equivalent |
| K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | Oct 7, 2003 | Substantially Equivalent |
| K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | Aug 25, 2003 | Substantially Equivalent |
| K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | Aug 25, 2003 | Substantially Equivalent |