Identity
- Trade Name
- Ortho Dots FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- Ortho Dots ® CLEAR Patient Packs4-count FDA UDI
- Model / Reference
- 55-K710-0000 FDA UDI
- Description
- Ortho Dots ® CLEAR Patient Packs4-count FDA UDI
Identifiers
- Catalog Number
- 55-K710-0000 FDA UDI
- Primary DI / UDI-DI
- E53555K71000001 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ortho Dots by GC Orthodontics America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- GC Orthodontics America Inc.
Sources (1)
- FDA UDI 11902a3f-e0bf-41aa-ab88-a564b8c6367a 36 fields · synced Jun 1, 2026