Identity
- Trade Name
- 3M™ ESPE™ FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- 3M™ ESPE™ Stainless Steel First Primary Molar Replacement Crown, Upper Left (5/pack), Size D-UL-6, DUL6 FDA UDI
- Model / Reference
- DUL6 FDA UDI
- Description
- 3M™ ESPE™ Stainless Steel First Primary Molar Replacement Crown, Upper Left (5/pack), Size D-UL-6, DUL6 FDA UDI
Identifiers
- Catalog Number
- DUL6 FDA UDI
- Primary DI / UDI-DI
- 30605861022034 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Preformed dental crown, temporary
3m™ Espe™ by 3m Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Preformed dental crown, temporary.
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- NuSmile Pre-Contoured Stainless Steel Cuspid Crown - Mandibular, Size 2 — NUSMILE, LTD · Class I
- Acero Crowns XT Molar — PARK-ISTRE, LLC. · Class I
- NuSmile ZR Posterior Replacement Crown — NUSMILE, LTD · Class I
- NuSmile Pre-Contoured Stainless Steel Crown — NUSMILE, LTD · Class I
- NuSmile ZR Posterior Replacement Crown - First Primary Molar Maxillary Right, Si — NUSMILE, LTD · Class I
- Kids-e-crown — Kids-E-Dental Llp · Class I
- NuSmile BioFlx Posterior Replacement Crown - First Primary Molar — NUSMILE, 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
- 3m Company
Sources (1)
- FDA UDI 56591633-3a00-4700-87dd-c793c5e1f9f7 35 fields · synced Jun 7, 2026