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NuSmile Pre-Countered Stainless Steel Crowns First Primary Professional Kit
FDA UDIClass I (US FDA UDI)
by Nusmile, Ltd
Identity
- Trade Name
- NuSmile Pre-Countered Stainless Steel Crowns First Primary Professional Kit FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- NuSmile Pre-Countered Stainless Steel Crowns First Primary Professional Kit - 120 FDA UDI
- Model / Reference
- PKD606 FDA UDI
- Description
- NuSmile Pre-Countered Stainless Steel Crowns First Primary Professional Kit - 120 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118101328 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 Pre-Countered Stainless Steel Crowns First Primary Professional Kit by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Preformed dental crown, temporary.
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- 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 5a6d226e-6af1-4d5b-9e54-5cf4b0ff5f8e 33 fields · synced May 30, 2026