FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLO DENTAL UNIT
K Number: K854647
·
Decision Jun 5, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
62
Applicant Total
10
Review Days
198
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Basic Information
- Device Name
- POLO DENTAL UNIT
- K Number
- K854647
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alpine Dental Equipment Co.
- Date Received
- November 19, 1985
- Decision Date
- June 5, 1986
- 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 Alpine Dental Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K880475 | SKEMA (DENTAL UNIT) | Sep 23, 1988 | Substantially Equivalent |
| K880474 | AREA (DENTAL CHAIR) | Sep 23, 1988 | Substantially Equivalent |
| K854642 | SOLAR CART | Mar 14, 1986 | Substantially Equivalent |
| K854643 | SOLAR | Mar 14, 1986 | Substantially Equivalent |
| K854645 | GOLD AIR, GOLD LIGHT | Mar 12, 1986 | Substantially Equivalent |
| K854641 | SOLAR F | Mar 10, 1986 | Substantially Equivalent |
| K854741 | X-RANGE 65 | Mar 6, 1986 | Substantially Equivalent |
| K854646 | VEGA DENTAL OPERATING LIGHT | Mar 6, 1986 | Substantially Equivalent |
| K854644 | MANTA DENTAL CHAIR | Jan 23, 1986 | Substantially Equivalent |