Identity
- Trade Name
- JJ CARE FDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- JJ CARE Temporary Tooth Cement- Zinc Oxide Eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. FDA UDI
- Model / Reference
- 30023 FDA UDI
- Description
- JJ CARE Temporary Tooth Cement- Zinc Oxide Eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060988910045 FDA UDI
- FDA Product Code
- EMB FDA UDI
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
Jj Care by Jack Jack Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zinc oxide eugenol dental cement.
- MARK3 — CARGUS INTERNATIONAL, INC · Class II
- Maquira — Maquira Industria de Produtos Odontologicos S/A · Class I
- ZOE B&T® Base and Temporary Filling Material — Dentsply International · Class I
- Fynal® Crown & Bridge Cement — Dentsply International · Class II
- Eugenol B.P. Liquid 150ml — ASSOCIATED DENTAL PRODUCTS LIMITED · Class I
- TempoLok NE Cement 2x5ml syringe, 20 mixing tips — Sterngold Dental LLC · Class II
- ZINROC LIQUID — Temrex Corp. · Class II
- Zoer Quick — Dsi Dental Solutions, Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Jack Jack Llc
Sources (1)
- FDA UDI e8a63c0d-f370-40ac-9d11-dcee8993e346 35 fields · synced May 30, 2026