Identity
- Trade Name
- PERFECtray® FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- PERFECTRAY QUAD UP LT/LW RT #8 FDA UDI
- Model / Reference
- SPD1407 FDA UDI
- Description
- PERFECTRAY QUAD UP LT/LW RT #8 FDA UDI
Identifiers
- Catalog Number
- SPD1407 FDA UDI
- Primary DI / UDI-DI
- D813SPD14070 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
Yes
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: Dental impression tray, single-use
PERFECtray® by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI c4527d68-d110-48e0-a7db-c6ec6795b84b 35 fields · synced Jun 9, 2026