Identity
- Trade Name
- Endo-Eze Tips EUDAMEDEndo-Eze Tip FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDEndo-Eze Tips 22g 20pk FDA UDIEndo-Eze Tips 19g 20pk FDA UDIEndo-Eze Tips 20g 20pk FDA UDI
- Model / Reference
- 347 EUDAMEDFDA UDI346 EUDAMEDFDA UDI348 EUDAMEDFDA UDI
- Description
- Endo-Eze Tips 22g 20pk FDA UDIEndo-Eze Tips 19g 20pk FDA UDIEndo-Eze Tips 20g 20pk FDA UDI
Identifiers
- Catalog Number
- 348 FDA UDI346 FDA UDI347 FDA UDI
- Primary DI / UDI-DI
- 00883205021748 EUDAMEDFDA UDI00883205021731 EUDAMEDFDA UDI00883205021755 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 Tips 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 (9)
- EUDAMED 286135e0-5f4a-4b7b-90c4-00762708f58c 61 fields · synced Sep 17, 2026
- EUDAMED 41bd4aa7-bc53-4488-86ba-ff67dab40b4c 61 fields · synced May 17, 2026
- EUDAMED 0570f51d-2c95-4c5d-a778-4c551c0f5c39 61 fields · synced May 17, 2026
- FDA UDI aee581d3-c2a9-43ac-97b3-f04774da3985 35 fields · synced May 29, 2026
- FDA UDI d52d2100-a45f-4d5d-b4d1-939a76c3d62d 35 fields · synced May 30, 2026
- FDA UDI 98c0ebeb-275f-4ce5-9809-e53584afd181 35 fields · synced May 30, 2026
- EUDAMED 570a7d73-bf10-4b2d-a4a1-e94631f8477f 61 fields · synced Jul 9, 2026
- EUDAMED 05a4f724-f8a8-42f5-bdc8-f596a7e3b013 61 fields · synced Jul 26, 2026
- EUDAMED 2bbc97e4-7ce4-47fd-9e37-e4ed37ba87c9 61 fields · synced Sep 17, 2026