FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRANE ACRYLIC HERBST APPLIANCE
K Number: K140429
·
Decision Sep 11, 2014
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
2
Review Days
204
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Basic Information
- Device Name
- CRANE ACRYLIC HERBST APPLIANCE
- K Number
- K140429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crane Dental Laboratory, Inc.
- Date Received
- February 19, 2014
- Decision Date
- September 11, 2014
- Product Code
- LRK
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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Other Clearances by Crane Dental Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181416 | Sapphire Dorsal Comfort Fit | Sep 17, 2019 | Substantially Equivalent |