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Cavex Alginate Orthotrace 20x500g

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref AA380Model Cavex Alginate Impression Materials510(k) K051207

by Cavex Holland BV

Identity

Trade Name
Cavex Alginate Orthotrace 20x500g EUDAMED
Cavex Orthotrace FDA UDI
Generic Name
Alginate dental impression material FDA UDI
Device Name
Dental Alginate Impression material FDA UDI
Model / Reference
Cavex Alginate Impression Materials EUDAMED
AA380 EUDAMEDFDA UDI
Description
Dental Alginate Impression material FDA UDI

Identifiers

Catalog Number
AA380 FDA UDI
Primary DI / UDI-DI
E241AA3801 EUDAMEDFDA UDI
Basic UDI-DI
++E241AA000LX EUDAMED
Direct Marketing DI
E241AA3801 EUDAMED
FDA Product Code
ELW FDA UDI
EMDN Code
Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
GMDN Term
Alginate dental impression material FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
872.3660 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Weight — 10 Kilogram FDA UDI

Cavex Alginate Orthotrace 20x500g by Cavex Holland BV — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Manufacturer's product page: Cavex Orthotrace

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Cavex Holland BV
EUDAMED SRN
NL-MF-000000423

Sources (3)

  • EUDAMED c5360f17-7e54-48bd-91f2-7984609ea5bc 85 fields · synced Jun 19, 2026
  • FDA UDI 9321da22-5c7b-46f6-ae7c-d8f25968e2e7 37 fields · synced May 30, 2026
  • FDA 510(k) K051207 1 fields · synced May 18, 2026