Identity
- Trade Name
- Elliot’s Separator 1pc(s) EUDAMEDDENTECH FDA UDI
- Generic Name
- Orthodontic separator FDA UDI
- Device Name
- KSK Sectional Matrix Ring EUDAMED
- Model / Reference
- 01071000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218662064 EUDAMEDFDA UDI
- Basic UDI-DI
- 456021866dentech3320401NZ EUDAMED
- Direct Marketing DI
- 04560218662064 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Orthodontic separator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany 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
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
Moist Heat or Steam Sterilization FDA UDI
Elliot’s Separator 1pc(s) 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 | 456021866dentech3320401NZ | 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 65a388f7-0c18-4c51-b150-57fe9a6145de 61 fields · synced Jul 9, 2026
- FDA UDI edc728de-e9ce-417d-b9fe-e09fbdfdee49 32 fields · synced May 30, 2026