Identity
- Trade Name
- Micro Capillary Tips EUDAMEDMicro Capillary Tip FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDMicro Capillary Tips, 5mm 100pk FDA UDI
- Model / Reference
- 1802 EUDAMEDFDA UDI
- Description
- Micro Capillary Tips, 5mm 100pk FDA UDI
Identifiers
- Catalog Number
- 1802 FDA UDI
- Primary DI / UDI-DI
- 00883205022479 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
Micro Capillary Tips by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material injection cannula, single-use.
- Clinician's Choice® Needle Tubes & Plugs — Den-Mat Holdings, LLC · Class I
- PRIME|ONE — Akzenta International SA · Class I
- CanalPro™ Color Syringes — Coltène/Whaledent AG · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- Avalon Biomed NeoSEALER 20 Flex Flo Tips — NUSMILE, LTD · Class I
- EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- PRIME|ONE — Akzenta International SA · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · 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 | 0883205-TF032AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (3)
- EUDAMED 05ee05fa-17e4-4f54-a9cf-96696e2bdd8f 61 fields · synced Jun 19, 2026
- FDA UDI 679d5ae3-b4a5-478f-a874-87b7f848cda2 35 fields · synced May 27, 2026
- EUDAMED 8d8bbd49-52e9-4cfd-b5f7-63f88d8c3d41 61 fields · synced Jun 19, 2026