Identity
- Trade Name
- X-Smart Pro+ EUDAMEDX-Smart Pro FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Endo Tabletop EUDAMEDX-Smart Pro+ FDA UDI
- Model / Reference
- 6779016 EUDAMEDFDA UDI
- Description
- X-Smart Pro+ FDA UDI
Identifiers
- Catalog Number
- 6779016 FDA UDI
- Primary DI / UDI-DI
- +E27667790160 EUDAMEDE27667790160 FDA UDI
- Basic UDI-DI
- ++E276EndoTTV01SV EUDAMED
- FDA Product Code
- LQY FDA UDIEKX FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental surgical power tool motorized handpiece/set, electric
X-Smart Pro by Sirona Dental Systems GmbH — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, electric.
- WE-99 LED G — W & H Dentalwerk Bürmoos GmbH · Class I
- S-9 LG surgical handpiece 1:1 — W & H Dentalwerk Bürmoos GmbH · Class II
- WG-57 LT — W & H Dentalwerk Bürmoos GmbH · Class I
- MAXSO — Beyes Dental Canada Inc · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Medidenta — Medidenta · Class I
- StarDental — DENTALEZ, INC. · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Sirona Dental Systems GmbH
Sources (2)
- FDA UDI 6d37861e-ee2d-4d69-9c72-eccdcb32cfa4 35 fields · synced Oct 9, 2026
- EUDAMED d84daccc-54c8-4a13-a9d1-2e1116530949 61 fields · synced Oct 8, 2026