FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
K Number: K043325
·
Decision Feb 11, 2005
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
- K Number
- K043325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rolence Enteprise, Inc.
- Date Received
- December 2, 2004
- Decision Date
- February 11, 2005
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Rolence Enteprise, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Apr 22, 2004 | Substantially Equivalent |