Identity
- Trade Name
- UltraSeal XT plus EUDAMEDUltraSeal XT FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- UltraSeal XT Plus EUDAMEDUltraSeal XT plus Shade A1 Refill FDA UDI
- Model / Reference
- 1289 EUDAMEDFDA UDI
- Description
- UltraSeal XT plus Shade A1 Refill FDA UDI
Identifiers
- Catalog Number
- 1289 FDA UDI
- Primary DI / UDI-DI
- 00883205104106 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF018UltraSeXTXU EUDAMED
- FDA Product Code
- EBC FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3765 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental unfilled resin sealant/coating
UltraSeal XT by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental unfilled resin sealant/coating.
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- ProRoot MTA — TULSA DENTAL PRODUCTS LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI f6a49583-44f6-45d6-a454-a629cb5aff06 36 fields · synced Oct 5, 2026
- EUDAMED f064d4da-50fd-4de0-9379-6d3ae04dc177 61 fields · synced Oct 5, 2026