Identity
- Trade Name
- Inspiral Brush Tips EUDAMEDInspiral Brush Tip FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDInspiral Brush Tips 100pk FDA UDI
- Model / Reference
- 123 EUDAMEDFDA UDI
- Description
- Inspiral Brush Tips 100pk FDA UDI
Identifiers
- Catalog Number
- 123 FDA UDI
- Primary DI / UDI-DI
- 00883205021571 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- KXR 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
- 872.3140 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
Inspiral Brush 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 (3)
- EUDAMED d7a6a15d-1450-4df8-8bbd-54d0dac6ca9a 61 fields · synced Jul 15, 2026
- FDA UDI d25cfb9c-d86e-4434-a111-28c860dce8a4 35 fields · synced May 30, 2026
- EUDAMED e6045686-ef45-416b-b225-d742166aa89c 61 fields · synced Jul 15, 2026