Identity
- Trade Name
- TEMPSMART™ FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- TEMPSMART™ 48mL Mixing Tip II SSS (20) FDA UDI
- Model / Reference
- 420000 FDA UDI
- Description
- TEMPSMART™ 48mL Mixing Tip II SSS (20) FDA UDI
Identifiers
- Catalog Number
- 420000 FDA UDI
- Primary DI / UDI-DI
- 10386040012492 FDA UDID6584200001 FDA UDI
- 510(k) Number
- K141562 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material application tool, single-use
Tempsmart™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141562 also covers:
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
- TEMPSMART™ — Gc America Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (2)
- FDA UDI 1cee27e8-03d3-4950-a1c4-a9f63dafebbd 37 fields · synced Jun 6, 2026
- FDA UDI a0697956-ae48-4800-bca0-07912808063f 37 fields · synced May 27, 2026