Identity
- Trade Name
- TempoLok NE Cement 2x5ml syringe, 20 mixing tips FDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. The TempoLok™ NE includes: 2- 5ml Syringes and 20 Mixing Tips of non-eugenol, zinc oxide cement. FDA UDI
- Model / Reference
- 220265 FDA UDI
- Description
- Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. The TempoLok™ NE includes: 2- 5ml Syringes and 20 Mixing Tips of non-eugenol, zinc oxide cement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100468 FDA UDI
- 510(k) Number
- K984340 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Zinc oxide eugenol 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
Yes
FDA UDI
Category: Zinc oxide eugenol dental cement
TempoLok NE Cement 2x5ml syringe, 20 mixing tips by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sterngold Dental LLC
Sources (1)
- FDA UDI 8350e3d3-3e9e-4565-b8c5-4d05460d201a 35 fields · synced May 30, 2026