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Perfect Clear Ii
EUDAMEDClass IIa (EU MDR)
Ref 240-32-5Model PERFECT CLEAR ∥ STANDARD018 #32
Identity
- Trade Name
- PERFECT CLEAR II EUDAMED
- Model / Reference
- PERFECT CLEAR ∥ STANDARD018 #32 EUDAMED240-32-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033421054 EUDAMED
- Basic UDI-DI
- B-08800033421054 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
The PERFECT CLEAR II device is a Class IIa dental device designed for the treatment of dentofacial deformities, particularly orthodontic anchorage. It features a unique combination of mechanical stability and tissue-level anchorage, providing optimal results for patients.
Similar devices
Also classified as Orthodontic tube.
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- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- 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-08800033421054 | 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 c9849dd0-def6-4953-a478-521c120e00b8 61 fields · synced Jun 22, 2026