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Intraoral tips
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2139Ref 2142Ref 2140
by VOCO GmbH
Identity
- Trade Name
- Intraoral tips EUDAMEDFDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Intraoral tips EUDAMEDIntraoral tips type 1 FDA UDIIntraoral tips type 2 FDA UDIIntraoral tips type 4 FDA UDI
- Model / Reference
- 2139 EUDAMEDFDA UDI2140 EUDAMEDFDA UDI2142 EUDAMEDFDA UDI
- Description
- Intraoral tips type 1 FDA UDIIntraoral tips type 2 FDA UDIIntraoral tips type 4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E22121391 EUDAMEDFDA UDIE22121401 EUDAMEDFDA UDIE22121421 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E22101400300000008T 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material mixing nozzle
Intraoral tips by VOCO GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E22101400300000008T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (6)
- EUDAMED 9f5a52da-2f6f-4bc5-99c5-3fa2b5812052 61 fields · synced Jul 20, 2026
- FDA UDI 7577a052-c73f-40a9-9bac-5203afb9399a 34 fields · synced May 27, 2026
- FDA UDI eea7a5f0-7aee-4051-981a-d07dde349cdd 34 fields · synced May 30, 2026
- FDA UDI 64d0dc41-6b37-4ce3-b5f4-b59fd6489c46 34 fields · synced May 30, 2026
- EUDAMED 568a48bf-1efd-48bc-bf2b-3cac36e986e1 61 fields · synced Jul 17, 2026
- EUDAMED ed196966-0ae8-4697-9137-7c9f2e2458a8 61 fields · synced Jul 20, 2026