Identity
- Trade Name
- Estelite Sigma Quick FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Syringe CE FDA UDI
- Model / Reference
- 13127 FDA UDI
- Description
- Syringe CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548190131273 FDA UDI
- 510(k) Number
- K080940 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
Category: Dental composite resin
Estelite Sigma Quick by Tokuyama Dental Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080940 also covers:
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
- Estelite Sigma Quick — TOKUYAMA DENTAL CORPORATION
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
- Tokuyama Dental Corporation
Sources (1)
- FDA UDI 9e8556e0-94de-4ba0-8c0b-86f48cc05565 36 fields · synced Jun 8, 2026