Identity
- Trade Name
- IN-OVATION® R FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- IN-OVATION® R RNC 022/LL4 - 5 -7T-1A2DHK FDA UDI
- Model / Reference
- 189-442-61 FDA UDI
- Description
- IN-OVATION® R RNC 022/LL4 - 5 -7T-1A2DHK FDA UDI
Identifiers
- Catalog Number
- 189-442-61 FDA UDI
- Primary DI / UDI-DI
- D807189442611 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
In-Ovation® R by Dentsply Sirona Orthodontics 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
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI 8d66ea7c-989f-4a63-ace5-b2f1827ff177 36 fields · synced Jun 9, 2026