FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Dental Pain Eraser
K Number: K192429
·
Decision Jan 14, 2020
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
14
Applicant Total
2
Review Days
131
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Basic Information
- Device Name
- Dental Pain Eraser
- K Number
- K192429
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synapse Dental
- Date Received
- September 5, 2019
- Decision Date
- January 14, 2020
- Product Code
- LWM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LWM | Device, Electrical Dental Anesthesia | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWM), ordered by most recent decision date.
Dental Pain Eraser
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3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
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3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
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3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
FDA 510(k)
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·Unknown
Other Clearances by Synapse Dental
| K Number | Device Name | ||
|---|---|---|---|
| K193570 | Dental Pain Eraser | Jan 17, 2020 | Substantially Equivalent |