Identity
- Trade Name
- DuoTEMP FDA UDI
- Generic Name
- Zinc phosphate dental cement FDA UDI
- Model / Reference
- 5831 FDA UDI
Identifiers
- Catalog Number
- 5831 FDA UDI
- Primary DI / UDI-DI
- J00658310 FDA UDI
- 510(k) Number
- K072604 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Zinc phosphate 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 phosphate dental cement
DuoTEMP by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zinc phosphate dental cement.
- Mizzy Fleck's — Keystone Industries · Class II
- Mizzy Fleck's — Keystone Industries · Class II
- Harvard Cement quick setting, Clinic powder, Shade 15 — Harvard Dental International GmbH · Class II
- Harvard Cement normal setting, Single powder, Shade 4 — Harvard Dental International GmbH · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Harvard Cement normal setting, Single powder, Shade 3 — Harvard Dental International GmbH · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- MASTER-DENT — DENTONICS, INC.
Cleared under the same submission
K072604 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
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 8f31b4aa-6812-4e4c-8512-84409a991cc0 36 fields · synced Jun 8, 2026