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Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z457
Identity
- Trade Name
- Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 Count EUDAMEDInsti-Dam® FDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- Non-Sterile Dental Isolation and Barrier Devices – Single Use EUDAMEDInsti-Dam Relaxed Fit 20pk FDA UDI
- Model / Reference
- 50Z457 EUDAMEDFDA UDI
- Description
- Insti-Dam Relaxed Fit 20pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840161302714 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000335 EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Rubber dam, Hevea-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 121 Millimeter FDA UDIWidth — 124 Millimeter FDA UDIHeight — 70 Millimeter FDA UDI
Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08401613000335 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 b8481105-8671-4c90-85de-ba53be28b3c2 61 fields · synced Jun 18, 2026
- FDA UDI cd6391f3-e1a3-40bb-8617-45433e090b0e 34 fields · synced May 29, 2026