← Back to catalogue
Extc4it
EUDAMEDClass I (EU MDR)
Ref EXTC4ITModel Dental Instruments Class I, Extraction Kit
Identity
- Model / Reference
- Dental Instruments Class I, Extraction Kit EUDAMEDEXTC4IT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435567312778 EUDAMED
- Basic UDI-DI
- 084355673KITEXTJ3 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical screwdriver, reusable
Extc4it by Phibo Dental Solutions S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084355673KITEXTJ3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phibo Dental Solutions S.L.
- EUDAMED SRN
- ES-MF-000024464
Sources (1)
- EUDAMED ee683e18-caeb-447d-a30e-7c5f558a2b3c 61 fields · synced Jun 18, 2026