Identity
- Trade Name
- Tooth Shade Resin Material FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Model / Reference
- SLT-S-BL2-D(98-16) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942201735852 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dentine bonding agent/set 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Dentine bonding agent/set
Tooth Shade Resin Material by Liaoning Upcera Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
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- Name: Ena Bond Seal Model: Light curing Sealer bonding agent Resin — Micerium S.p.A. · Class IIa
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- Monobond Etch Prime — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Liaoning Upcera Co., Ltd.
Sources (1)
- FDA UDI b93f222c-1b48-4bc0-8090-6a7804a051a9 32 fields · synced Jun 1, 2026