FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
OT EQUATOR
K Number: K142211
·
Decision Nov 25, 2015
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
1
Review Days
470
Basic Information
- Device Name
- OT EQUATOR
- K Number
- K142211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhein '83 SRL
- Date Received
- August 12, 2014
- Decision Date
- November 25, 2015
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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