Identity
- Trade Name
- Mischkanülen EUDAMEDMixing tips FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Mischkanülen EUDAMEDMixing tips type 19 FDA UDI
- Model / Reference
- 2199 EUDAMEDFDA UDI
- Description
- Mixing tips type 19 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E22121991 EUDAMEDE2212191 FDA UDI
- Basic UDI-DI
- ++E2210140060000000AL EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
- GMDN Term
- Dental material mixing nozzle 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental material mixing nozzle
Discover the Mixing Tips device, a crucial tool for dental professionals to create functional dental restorative/impression materials. With its nozzle-shaped design and integral mixing mechanism, this single-use device is designed for precise compound mixing during dental procedures.
Similar devices
Also classified as Dental material mixing nozzle.
- Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
- 3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Imprint™ 4 Regular — 3M Deutschland GmbH · Class II
- Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI be6cc839-5e92-42cf-be71-6ff6fb9fa736 34 fields · synced Oct 6, 2026
- EUDAMED 4b67e4d9-db11-47e1-a0d7-b280fee97176 61 fields · synced Jun 19, 2026