Identity
- Trade Name
- Sticky Tim FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Sticky Tim EUDAMED
- Model / Reference
- 2248 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2248 FDA UDI
- Primary DI / UDI-DI
- E22122481 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E22101401300000009J EUDAMED
- FDA Product Code
- FRL FDA UDI
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Sticky Tim 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.
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- 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 | ++E22101401300000009J | 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 (2)
- EUDAMED 95f596b8-1f23-4292-8b04-c1ea4c988587 61 fields · synced Jul 8, 2026
- FDA UDI 32ffbd3c-7991-4746-b794-ba19c3cb6d5c 34 fields · synced May 30, 2026