Identity
- Trade Name
- Night Guard FDA UDI
- Generic Name
- Mouthguard, reusable FDA UDI
- Device Name
- Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient FDA UDI
- Model / Reference
- Printed Night Guard FDA UDI
- Description
- Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073333013 FDA UDI
- 510(k) Number
- K202465 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Mouthguard, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mouthguard, reusable
Night Guard by 3d Diagnostix, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- 3d Diagnostix, Inc.
Sources (1)
- FDA UDI c15f02f1-151d-401e-b968-e8d815cdea3f 34 fields · synced May 30, 2026