Identity
- Trade Name
- Polycarboxylate FDA UDI
- Generic Name
- Zinc polycarboxylate dental cement FDA UDI
- Device Name
- HY-BOND POLY POWDER FDA UDI
- Model / Reference
- 1161 FDA UDI
- Description
- HY-BOND POLY POWDER FDA UDI
Identifiers
- Catalog Number
- 1161 FDA UDI
- Primary DI / UDI-DI
- E23511610 FDA UDI
- 510(k) Number
- K002461 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Zinc polycarboxylate 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
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: Zinc polycarboxylate dental cement
Polycarboxylate by Shofu Dental Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zinc polycarboxylate dental cement.
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- Durelon™ — 3M Deutschland GmbH · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Tylok® Plus Anhydrous Polycarboxylate Cement — Dentsply International · Class II
- Durelon™ — 3M Deutschland GmbH · Class II
- Durelon™ — 3M Deutschland GmbH · Class II
Cleared under the same submission
K002461 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA UDI f0c9aec3-c080-47e8-9b37-db5ec621f188 36 fields · synced Jun 8, 2026