Identity
- Trade Name
- T-Mixer light blue 1:1 / 2:1 FDA UDI
- Generic Name
- Dental impression material syringe, reusable FDA UDI
- Model / Reference
- 03812 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDET038121 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Dental impression material syringe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental impression material syringe, reusable
T-Mixer light blue 1:1 / 2:1 by DETAX GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material syringe, reusable.
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- Plasdent — PLASDENT CORP. · Class I
- Astek — Young Innovations, Inc. · Class I
- COE SYRINGE — Gc America Inc. · Class I
- Astek — Young Innovations, Inc. · Class I
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH
Sources (1)
- FDA UDI 9a4b352c-5141-49b3-b84d-6b704f01c0a1 32 fields · synced Jun 1, 2026