Metal Dento-Infusor Tip with Comfort Hub
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Metal Dento-Infusor Tip with Comfort Hub EUDAMEDTips FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Tips EUDAMEDMetal Dento-Infusor Tip 19G Comfort Hub 100pk FDA UDIMetal Dento-Infusor Tip 19G Comfort Hub 500pk FDA UDIMetal Dento-Infusor Tip 19G Comfort Hub 20pk FDA UDI
- Model / Reference
- 4956 EUDAMEDFDA UDI4955 EUDAMEDFDA UDI4954 EUDAMEDFDA UDI
- Description
- Metal Dento-Infusor Tip 19G Comfort Hub 100pk FDA UDIMetal Dento-Infusor Tip 19G Comfort Hub 500pk FDA UDIMetal Dento-Infusor Tip 19G Comfort Hub 20pk FDA UDI
Identifiers
- Catalog Number
- 4955 FDA UDI4956 FDA UDI4954 FDA UDI
- Primary DI / UDI-DI
- 00883205034694 EUDAMEDFDA UDI00883205034687 EUDAMEDFDA UDI00883205034670 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental material injection cannula, single-use
Metal Dento-Infusor Tip with Comfort Hub 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
CE/MDR
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 c452f8fd-ae4a-4766-b3b2-0b10369b9c97 61 fields · synced Aug 5, 2026
- EUDAMED 61988798-7e1e-48ad-9905-98bd24763f53 61 fields · synced May 17, 2026
- EUDAMED 486e19b1-489f-4472-bc21-95d68452daf7 61 fields · synced May 17, 2026
- FDA UDI 34583382-1eda-4b76-b015-b76b434c0ad5 35 fields · synced May 26, 2026
- FDA UDI 98fb2275-6b4f-4947-8aad-045beead2c59 35 fields · synced May 30, 2026
- FDA UDI 93b9440e-073d-4532-96ea-ed575408fb87 35 fields · synced May 30, 2026
- EUDAMED 2018060b-ca51-4650-ab70-a7103e94fa83 61 fields · synced Jul 13, 2026
- EUDAMED 6cb9e63d-ccf3-45fc-830e-a4339c8034ed 61 fields · synced Jul 14, 2026
- EUDAMED 876f3c73-9451-4f17-80b2-e86908eb33e7 61 fields · synced Aug 5, 2026