Identity
- Trade Name
- GUM® FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- ORTHODONTIC KIT FDA UDI
- Model / Reference
- 124 FDA UDI
- Description
- ORTHODONTIC KIT FDA UDI
Identifiers
- Catalog Number
- PQ; RQB FDA UDI
- Primary DI / UDI-DI
- 00070942306799 FDA UDI
- FDA Product Code
- EFW FDA UDIJES FDA UDIEGD FDA UDI
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 FDA UDI872.6390 FDA UDI872.6890 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental flossBasic manual toothbrushOrthodontic appliance relief material
Gum® by Sunstar Americas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PATIENT RELIEF WAX — Ortho Organizers, Inc. · Class I
- JMU — JMU DENTAL, INC · Class I
- Ortho Pro — Ortho Pro Dent 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
- Sunstar Americas, Inc.
Sources (1)
- FDA UDI 463b8789-5c04-4dd5-b9be-7c1fba980845 35 fields · synced May 30, 2026