Identity
- Trade Name
- FLAT AC EUDAMED
- Model / Reference
- 20PCS,34,UR6,C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- PUFLAXX34R6XC2 EUDAMED
- Basic UDI-DI
- B-PUFLAXX34R6XC2 EUDAMED
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Partial denture
The FLAT AC device is a medical device designed for the treatment of dental implant failures, providing a stable and secure platform for implant placement. It features a unique design, allowing for easy removal and repositioning of implants, making it an ideal solution for patients with compromised jawbone or other skeletal issues.
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Also classified as Partial denture.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-PUFLAXX34R6XC2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
- EUDAMED SRN
- JP-MF-000024849
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e93254b2-a45a-4a03-b939-5d656699bc6f 61 fields · synced Jul 21, 2026