FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GOLD AIR, GOLD LIGHT
K Number: K854645
·
Decision Mar 12, 1986
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
10
Review Days
113
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Basic Information
- Device Name
- GOLD AIR, GOLD LIGHT
- K Number
- K854645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alpine Dental Equipment Co.
- Date Received
- November 19, 1985
- Decision Date
- March 12, 1986
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 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 |
| K854647 | POLO DENTAL UNIT | Jun 5, 1986 | Substantially Equivalent |
| K854642 | SOLAR CART | Mar 14, 1986 | Substantially Equivalent |
| K854643 | SOLAR | Mar 14, 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 |