Identity
- Trade Name
- Ultradent MTApex Sealer FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- Ultradent MTApex Bioceramic Root Canal Sealer (Premixed) 4 pack FDA UDI
- Model / Reference
- 5958 FDA UDI
- Description
- Ultradent MTApex Bioceramic Root Canal Sealer (Premixed) 4 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118103988 FDA UDI
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Weight — 2.2 Gram FDA UDI
Category: Hygroscopic dental cement
Ultradent MTApex Sealer by Nusmile, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hygroscopic dental cement.
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- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
- Komet BioRepair — Angelus Industria de Produtos Odontologicos S A · Class II
- AH Plus Bioceramic Sealer — MARUCHI · Class II
- AHLGeneric — ADVANCED HEALTHCARE LTD. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nusmile, Ltd
Sources (1)
- FDA UDI 5aa838c8-8d2b-4c65-8e6a-0a023ab01cb8 35 fields · synced Jun 8, 2026