Identity
- Trade Name
- TherTray1 3/4/-Arch UL-LR FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials. FDA UDI
- Model / Reference
- 116 FDA UDI
- Description
- Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859787002086 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
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TherTray1 3/4/-Arch UL-LR by Advantage Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Advantage Dental Products, Inc.
Sources (1)
- FDA UDI 9d7f2ba7-f1bc-432f-aacb-e3a91540dcad 36 fields · synced May 30, 2026