FDA 510(k)
FDA class 1
Substantially Equivalent
🇳🇱 Netherlands
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
K Number: K002693
·
Decision Nov 9, 2000
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
10
Applicant Total
1
Review Days
72
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Basic Information
- Device Name
- CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
- K Number
- K002693
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cbs Intl. B.V.
- Date Received
- August 29, 2000
- Decision Date
- November 9, 2000
- Product Code
- EBL
- 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 |
|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | FDA class 1 | Dental |
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