← Back to catalogue
Cavex Impression Paste Outline
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref AP030Model Dental Impression Materials, other
Identity
- Trade Name
- Cavex Impression Paste Outline EUDAMED
- Device Name
- Cavex Outline EUDAMED
- Model / Reference
- Dental Impression Materials, other EUDAMEDAP030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241AP0300 EUDAMED
- Basic UDI-DI
- ++E241AP030QH EUDAMED
- Direct Marketing DI
- E241AP0300 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Silicone dental impression material
Cavex Impression Paste Outline by Cavex Holland BV — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Manufacturer's product page: Cavex Impressional
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052455 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++E241AP030QH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED 61c17c5e-b652-48a4-a46d-6f7461e1d0e1 61 fields · synced Jul 13, 2026
- FDA 510(k) K052455 1 fields · synced May 18, 2026