Identity
- Trade Name
- EQUIA® FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accessories) FDA UDI
- Model / Reference
- 452007 FDA UDI
- Description
- EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accessories) FDA UDI
Identifiers
- Catalog Number
- 452007 FDA UDI
- Primary DI / UDI-DI
- 10386040010535 FDA UDI
- 510(k) Number
- K091106 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glass ionomer dental cement
Equia® by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glass ionomer dental cement.
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- SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
- Prontolute Glass Ionomer Luting Cement 30g — ADVANCED HEALTHCARE LTD. · Class IIa
Cleared under the same submission
K091106 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
- Gc America Inc.
Sources (1)
- FDA UDI 20ff4d27-2e04-4149-b7ec-4f8c5e5dfa2b 37 fields · synced May 30, 2026