FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇪 Germany
SmileGuard
K Number: K220894
·
Decision Jun 10, 2022
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
5
Review Days
74
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Basic Information
- Device Name
- SmileGuard
- K Number
- K220894
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Envisiontec GmbH
- Date Received
- March 28, 2022
- Decision Date
- June 10, 2022
- Product Code
- MQC
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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