Identity
- Trade Name
- Planmeca Sovereign FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed treatment sequences as well as both left-handed and right-handed use. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease of use.The instrument console includes six instrument locations, with easy instrument interchange. FDA UDI
- Model / Reference
- Classic FDA UDI
- Description
- Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed treatment sequences as well as both left-handed and right-handed use. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease of use.The instrument console includes six instrument locations, with easy instrument interchange. FDA UDI
Identifiers
- Catalog Number
- 10032746, 10032747 FDA UDI
- Primary DI / UDI-DI
- 06430035420100 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Planmeca Sovereign by Planmeca Oy — 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
- Planmeca Oy
Sources (1)
- FDA UDI de47b4aa-93ac-404b-96f3-02d29fca546d 35 fields · synced May 30, 2026