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Quadrant Total Etch
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FE10Model Quadrant Bonding
Identity
- Trade Name
- Quadrant Total Etch EUDAMED
- Device Name
- Quadrant Total Etch EUDAMED
- Model / Reference
- Quadrant Bonding EUDAMEDFE10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241FE100 EUDAMED
- Basic UDI-DI
- ++E241FE1058 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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: Dental etching solution
Quadrant Total Etch by Cavex Holland BV — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
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 | K984043 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E241FE1058 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED fe8dfdf6-bbf5-451f-84bd-5a5708426746 61 fields · synced Jul 9, 2026
- FDA 510(k) K984043 1 fields · synced May 18, 2026