Opal Bond Flow Tips 20 Pack
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Opal Bond Flow Tips 20 Pack EUDAMEDOpal Bond Flow FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDOpal Bond Flow Tips 20 Pack FDA UDI
- Model / Reference
- 500079 EUDAMEDFDA UDI
- Description
- Opal Bond Flow Tips 20 Pack FDA UDI
Identifiers
- Catalog Number
- 500079 FDA UDI
- Primary DI / UDI-DI
- 00883205015549 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
- 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
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
No
Category: Dental material injection cannula, single-use
Opal Bond Flow Tips 20 Pack by Ultradent Products, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100301 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0883205-TF032AQ | Class I | Active |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (4)
- EUDAMED af7fe11f-57ba-4168-81a6-0a08abb158c7 85 fields · synced Jul 17, 2026
- FDA UDI 6c83768a-6e35-4dab-a5d9-fb13b6c5b28f 35 fields · synced May 30, 2026
- EUDAMED 9c9f94ed-ea2f-462c-8f07-fd01f4cbf2d6 61 fields · synced Jul 17, 2026
- FDA 510(k) K100301 1 fields · synced May 18, 2026