Identity
- Trade Name
- Intraoral tips EUDAMEDFDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Intraoral tips EUDAMEDIntraoral tips type 6 FDA UDI
- Model / Reference
- 2133 EUDAMEDFDA UDI
- Description
- Intraoral tips type 6 FDA UDI
Identifiers
- Catalog Number
- 2133 FDA UDI
- Primary DI / UDI-DI
- E22121331 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 FDA GUDID, EUDAMED — 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 Unknown
MDR
United States Pending data
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 f8c291de-4754-4fa4-b95b-11274114250f 35 fields · synced Jul 8, 2026
- EUDAMED b77d1ec4-9d80-40fa-a407-fe24c35b8b62 61 fields · synced Jun 18, 2026