FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmarTemp X1
K Number: K190930
·
Decision Sep 5, 2019
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
53
Review Days
148
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Basic Information
- Device Name
- SmarTemp X1
- K Number
- K190930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- April 10, 2019
- Decision Date
- September 5, 2019
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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