Identity
- Trade Name
- ExperTemp FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- ExperTemp B1 kit FDA UDI
- Model / Reference
- 6343 FDA UDI
- Description
- ExperTemp B1 kit FDA UDI
Identifiers
- Catalog Number
- 6343 FDA UDI
- Primary DI / UDI-DI
- 00883205032010 FDA UDI
- 510(k) Number
- K122039 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Preformed dental crown, temporary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Preformed dental crown, temporary
ExperTemp by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Preformed dental crown, temporary.
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- 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
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- Kids-e-crown — Kids-E-Dental Llp · Class I
Cleared under the same submission
K122039 also covers:
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Perfectemp®10 — Den-Mat Holdings, LLC
- Visalys Temp — Kettenbach GmbH & Co. KG
- Visalys Temp — Kettenbach GmbH & Co. KG
- Visalys Temp — Kettenbach GmbH & Co. KG
- Visalys Temp — Kettenbach GmbH & Co. KG
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (1)
- FDA UDI 195a20fc-8a89-46c4-b4f4-2954d3e8331d 37 fields · synced May 30, 2026