Identity
- Trade Name
- UltraCal XS EUDAMEDFDA UDI
- Generic Name
- Calcium hydroxide dental suspension FDA UDI
- Device Name
- UltraCal XS EUDAMEDUltraCal XS Mini Kit FDA UDI
- Model / Reference
- 1024 EUDAMEDFDA UDI
- Description
- UltraCal XS Mini Kit FDA UDI
Identifiers
- Catalog Number
- 1024 FDA UDI
- Primary DI / UDI-DI
- 00883205103987 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF017AU EUDAMED
- 510(k) Number
- K970114 FDA UDI
- FDA Product Code
- EJK FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Calcium hydroxide dental suspension FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3250 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
Yes
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: Calcium hydroxide dental suspension
UltraCal XS by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K970114 also covers:
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 c5b49294-7798-42aa-9578-2474b9d11fdb 37 fields · synced Jul 13, 2026
- EUDAMED c7d40b56-3017-4abc-92c6-7775c1162cc9 61 fields · synced Jul 13, 2026