Identity
- Trade Name
- MAP One Procedure Pack EUDAMED
- Device Name
- MAP System Procedure Pack EUDAMED
- Model / Reference
- 20296_PP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640159163589 EUDAMED
- Basic UDI-DI
- 0764015916PPMAPSYSTEMS2 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- MAP System is intended for the placement of the root canal repair material as part of a local obturation procedure. The local obturation is appropriate in the following clinical cases: • Pulp capping (orthograde application) • Iatrogenic root perforation (orthograde application) • Pathological root perforation (root (radicular) resorption) (orthograde application) • Apexification and apexogenesis of immature teeth (orthograde application) • Retro-obturation (retrograde application) • Cervical root resorption (retrograde application) EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
MAP One Procedure Pack by Produits Dentaires SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0764015916PPMAPSYSTEMS2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-PR-000045775
Sources (1)
- EUDAMED 71056605-2f88-4a99-b62a-449c28a7633e 61 fields · synced Jul 11, 2026