FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RANGE 65
K Number: K854741
·
Decision Mar 6, 1986
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
10
Review Days
101
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Basic Information
- Device Name
- X-RANGE 65
- K Number
- K854741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alpine Dental Equipment Co.
- Date Received
- November 25, 1985
- Decision Date
- March 6, 1986
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | 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 |
| K854645 | GOLD AIR, GOLD LIGHT | Mar 12, 1986 | Substantially Equivalent |
| K854641 | SOLAR F | Mar 10, 1986 | Substantially Equivalent |
| K854646 | VEGA DENTAL OPERATING LIGHT | Mar 6, 1986 | Substantially Equivalent |
| K854644 | MANTA DENTAL CHAIR | Jan 23, 1986 | Substantially Equivalent |