Identity
- Trade Name
- DISPOSABLE EDENTULOUS TRAYS LARGE LOWER FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Impression tray used for edentulous patients, can be heated and molded to fit patient's mouth. FDA UDI
- Model / Reference
- 7158231 FDA UDI
- Description
- Impression tray used for edentulous patients, can be heated and molded to fit patient's mouth. FDA UDI
Identifiers
- Catalog Number
- 7158231 FDA UDI
- Primary DI / UDI-DI
- 00723896025185 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression tray, single-use
Disposable Edentulous Trays Large Lower by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, 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
- Practicon, Inc.
Sources (1)
- FDA UDI 30099ee7-96bf-4d17-8bd7-4913c5c700e3 34 fields · synced Jun 1, 2026