Identity
- Trade Name
- Power Dental U.S.A., Inc. FDA UDI
- Generic Name
- Orthodontic ligature director FDA UDI
- Device Name
- ORTHODONTIC INS ORTHO SEAT FDA UDI
- Model / Reference
- N5846 FDA UDI
- Description
- ORTHODONTIC INS ORTHO SEAT FDA UDI
Identifiers
- Catalog Number
- N5846 FDA UDI
- Primary DI / UDI-DI
- D943N5846 FDA UDI
- FDA Product Code
- ECP FDA UDI
- GMDN Term
- Orthodontic ligature director FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Power Dental U.S.A., Inc. by Power Dental USA, 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
- Power Dental USA, Inc.
Sources (1)
- FDA UDI 443430ff-37d5-4bac-8f2c-6dcba64e40f6 36 fields · synced May 30, 2026