Identity
- Trade Name
- TEMP CANAL ENHANCED FDA UDI
- Generic Name
- Dental pulp-capping material FDA UDI
- Device Name
- 3 mL syringe FDA UDI
- Model / Reference
- TE3 FDA UDI
- Description
- 3 mL syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701TE32 FDA UDI
- 510(k) Number
- K120003 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Dental pulp-capping material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Category: Dental pulp-capping material
Temp Canal Enhanced by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pulp-capping material.
- Bosworth Hydrox — Harry J. Bosworth Co. · Class II
- Grey MTA Plus — Avalon Biomed Inc. · Class II
- NeoMTA Plus — Avalon Biomed Inc. · Class II
- NeoMTA Plus — Avalon Biomed Inc. · Class II
- Grey MTA Plus — Avalon Biomed Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Vivid CalLiner Self Cure Standard Package — PEARSON DENTAL SUPPLIES, INC. · Class II
- NeoMTA Plus — Avalon Biomed Inc. · Class II
Cleared under the same submission
K120003 also covers:
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI fcbd39ff-5478-48a4-b934-12734224ec9d 35 fields · synced Jun 9, 2026