Identity
- Trade Name
- Oral Relief Kitz FDA UDI
- Generic Name
- Dental restoration/appliance emergency fix kit FDA UDI
- Device Name
- A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips. FDA UDI
- Model / Reference
- 850035489055 FDA UDI
- Description
- A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips. FDA UDI
Identifiers
- Catalog Number
- ORN0006-01 FDA UDI
- Primary DI / UDI-DI
- 00850035489055 FDA UDI
- FDA Product Code
- NXZ FDA UDI
- GMDN Term
- Dental restoration/appliance emergency fix kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental restoration/appliance emergency fix kit
Oral Relief Kitz by Orthonu, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental restoration/appliance emergency fix kit.
- Braces Treatment Starter Kitz — ORTHONU, LLC · Class I
- Aligner Treatment Starter Kitz — ORTHONU, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Orthonu, Llc
Sources (1)
- FDA UDI f37d1a6b-b498-4020-980b-d7861bad5317 35 fields · synced Jun 8, 2026