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Insti-Dam® - Latex-Free Rubber Dam - 20 Count
EUDAMEDClass I (EU MDR)
Ref 50Z459
Identity
- Trade Name
- Insti-Dam® - Latex-Free Rubber Dam - 20 Count EUDAMED
- Device Name
- Non-Sterile Dental Isolation and Barrier Devices – Single Use EUDAMED
- Model / Reference
- 50Z459 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840161302694 EUDAMED10840161302691 EUDAMED
- Basic UDI-DI
- 08401613000335 EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Insti-Dam® - Latex-Free Rubber Dam - 20 Count by Zirc Dental Products, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08401613000335 | Class I | Active |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED 79bdf7cc-e434-4497-9936-b3160ca26153 61 fields · synced Jul 13, 2026
- EUDAMED 320e40f7-8aae-43a1-9953-3c88d3b1985c 61 fields · synced May 19, 2026