Identity
- Trade Name
- ZCAD TempEsthetic FDA UDI
- Generic Name
- Dental cusp, temporary FDA UDI
- Device Name
- Zirlux Temp Multi PMMA 71x20mm FDA UDI
- Model / Reference
- 9007869 FDA UDI
- Description
- Zirlux Temp Multi PMMA 71x20mm FDA UDI
Identifiers
- Catalog Number
- 9007869 FDA UDI
- Primary DI / UDI-DI
- 00304040006566 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Dental cusp, temporary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental cusp, temporary
ZCAD TempEsthetic by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cusp, temporary.
- ZCAD TempFix — HENRY SCHEIN, INC. · Class I
- ZCAD TempFix — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- ZCAD TempEsthetic — HENRY SCHEIN, INC. · Class I
- ZCAD TempEsthetic — HENRY SCHEIN, INC. · Class I
- ZCAD TempFix — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 320c7790-fc6d-4291-b86f-910108bc6c2d 34 fields · synced May 31, 2026