Identity
- Trade Name
- Pele Tim EUDAMEDFDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Pele Tim EUDAMEDPele Tim - No. 2 1.000 x Ø 5 mm FDA UDIPele Tim - No. 3 500 x Ø 8 mm FDA UDIPele Tim - No. 0 3.000 x Ø 3 mm FDA UDI
- Model / Reference
- 2250 EUDAMEDFDA UDI2253 EUDAMEDFDA UDI2254 EUDAMEDFDA UDI
- Description
- Pele Tim - No. 2 1.000 x Ø 5 mm FDA UDIPele Tim - No. 3 500 x Ø 8 mm FDA UDIPele Tim - No. 0 3.000 x Ø 3 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- E22122501 EUDAMEDFDA UDIE22122531 EUDAMEDFDA UDIE22122541 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210270000000000B4 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
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
Pele 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.
- 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 | ++E2210270000000000B4 | 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 d7e762cc-28d1-4821-bade-833ea4d35261 61 fields · synced Oct 6, 2026
- FDA UDI 2269fbd3-5310-4b65-b807-7d7f9f0f93c3 34 fields · synced May 30, 2026
- FDA UDI 04011feb-6f35-47f0-a8fc-6dc4d722cc8a 34 fields · synced May 30, 2026
- FDA UDI bdc0e48a-b845-4f49-8e45-e6340dc19e8d 34 fields · synced May 30, 2026
- EUDAMED 33174263-ec1b-43c7-8484-927e9713c789 61 fields · synced Jul 9, 2026
- EUDAMED db94b1c2-9e19-4c6f-9923-6697aaf10260 61 fields · synced Jul 9, 2026