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NuSmile ZR Narrow First Primary Molar Crowns Kit
FDA UDIClass I (US FDA UDI)
by Nusmile, Ltd
Identity
- Trade Name
- NuSmile ZR Narrow First Primary Molar Crowns Kit FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- NuSmile ZR Narrow First Primary Molar Crowns Mini Evaluation Kit - Light FDA UDI
- Model / Reference
- MEKD207L FDA UDI
- Description
- NuSmile ZR Narrow First Primary Molar Crowns Mini Evaluation Kit - Light FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810092938521 FDA UDI
- FDA Product Code
- ELZ FDA UDI
- GMDN Term
- Preformed dental crown, temporary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3330 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Preformed dental crown, temporary
NuSmile ZR Narrow First Primary Molar Crowns Kit by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Preformed dental crown, temporary.
- 3M™ Unitek™ — 3M COMPANY · Class I
- Acero Crowns XT Molar — PARK-ISTRE, LLC. · Class I
- Kids-e-crown — Kids-E-Dental Llp · Class I
- Directa Temporary Polycarbonate Crowns — Directa AB · Class I
- Directa Temporary Polycarbonate Crowns — Directa AB · Class I
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class I
- Acero Crowns ES - Light — PARK-ISTRE, LLC. · 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
- Nusmile, Ltd
Sources (1)
- FDA UDI 3284e7c3-ff39-4d25-8102-43f3524633b3 33 fields · synced May 31, 2026