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Perfect Clear
EUDAMEDClass IIa (EU MDR)
Ref 320-031KModel 320-031K PERFECT CLEAR MBT018
Identity
- Trade Name
- PERFECT CLEAR EUDAMED
- Model / Reference
- 320-031K PERFECT CLEAR MBT018 EUDAMED320-031K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033413455 EUDAMED
- Basic UDI-DI
- B-08800033413455 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
Perfect Clear is a Class IIa endodontic device designed for the removal of infected or damaged dentinal structures, providing precise apical seal placement and enhanced osseointegration. This device features a unique design with multiple access points and a specialized root canal filling system, allowing for efficient and effective treatment.
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Also classified as Orthodontic tube.
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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-08800033413455 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 269948a4-363d-40b0-800c-d06a1c859be6 61 fields · synced Jun 21, 2026