FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
K Number: K971063
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
62
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
- K Number
- K971063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- King Dental Corp.
- Date Received
- March 24, 1997
- Decision Date
- June 3, 1997
- Product Code
- KLC
- 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 |
|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | FDA class 1 | Dental |
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Other Clearances by King Dental Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | May 27, 1993 | Substantially Equivalent |