Identity
- Trade Name
- Metal Opal™ Seal Tips EUDAMEDOpal Seal FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDMetal Opal Seal Tips 100 Pack FDA UDI
- Model / Reference
- 500095 EUDAMEDFDA UDI
- Description
- Metal Opal Seal Tips 100 Pack FDA UDI
Identifiers
- Catalog Number
- 500095 FDA UDI
- Primary DI / UDI-DI
- 00883205015686 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
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
Metal Opal™ Seal 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 224e47aa-7150-4d7a-921c-bc0ea7a5f945 61 fields · synced Jun 19, 2026
- FDA UDI 55dd1f84-5593-46f5-92ed-335cedff296f 35 fields · synced May 30, 2026
- EUDAMED c1f30f6a-6091-4c9e-ad27-6a28425744c0 61 fields · synced Jun 19, 2026