FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CustMBite Dental Guard
K Number: K183315
·
Decision Aug 23, 2019
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
2
Review Days
266
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Basic Information
- Device Name
- CustMBite Dental Guard
- K Number
- K183315
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dental Choice Holdings, LLC
- Date Received
- November 30, 2018
- Decision Date
- August 23, 2019
- Product Code
- OBR
- 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 |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | FDA unclassified | Unknown |
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Other Clearances by Dental Choice Holdings, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K221322 | CUSTMBITE Snoring System | Oct 27, 2022 | Substantially Equivalent |