Identity
- Trade Name
- Endo-Eze Tip EUDAMEDFDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDEndo-Eze Tips 19g 100pk FDA UDIEndo-Eze Tips 20g 100pk FDA UDI
- Model / Reference
- 1429 EUDAMEDFDA UDI1430 EUDAMEDFDA UDI
- Description
- Endo-Eze Tips 19g 100pk FDA UDIEndo-Eze Tips 20g 100pk FDA UDI
Identifiers
- Catalog Number
- 1429 FDA UDI1430 FDA UDI
- Primary DI / UDI-DI
- 00883205022325 EUDAMEDFDA UDI00883205022332 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Syringe tip cap 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material injection cannula, single-use
Endo-Eze Tip by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0883205-TF032AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (5)
- EUDAMED 6f0dc617-1fba-4add-b9fb-379eec194308 61 fields · synced Jul 13, 2026
- EUDAMED bff7c719-c9ab-498f-aa3b-e938b00f4ce2 61 fields · synced May 18, 2026
- FDA UDI bd3f6db1-d821-445e-9669-dd85b496b658 35 fields · synced May 30, 2026
- FDA UDI 4a9fe7f6-6251-4935-83b2-3ec918618cb1 35 fields · synced May 30, 2026
- EUDAMED 02cf3270-9010-4947-a3a5-2be7e1d152fe 61 fields · synced Jul 13, 2026