Identity
- Trade Name
- Rubber Dam Technic set, Black EUDAMEDDENTECH FDA UDI
- Generic Name
- Rubber dam kit FDA UDI
- Device Name
- Rubber Dam isolation technique related products EUDAMEDRubber Dam Technic set, Black FDA UDI
- Model / Reference
- 01030110 EUDAMEDFDA UDI
- Description
- Rubber Dam Technic set, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218661456 EUDAMEDFDA UDI
- Basic UDI-DI
- 456021866dentech1571201QD EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Rubber dam kit FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Rubber Dam Technic set, Black by Dentech Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 456021866dentech1571201QD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentech Corporation
- EUDAMED SRN
- JP-MF-000046690
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e7e018e6-d2fe-4e47-b72c-86fe8fb6322c 61 fields · synced Jul 28, 2026
- FDA UDI 7fda11fa-e7f2-44fc-94fa-1c2ac0bfb01d 33 fields · synced May 30, 2026