Identity
- Trade Name
- Essix ACE® FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Essix ACE® Plastic - .035in Vac 5" Square FDA UDI
- Model / Reference
- 1AH50PLAS FDA UDI
- Description
- Essix ACE® Plastic - .035in Vac 5" Square FDA UDI
Identifiers
- Catalog Number
- 1AH50PLAS FDA UDI
- Primary DI / UDI-DI
- D7461AH50PLAS1 FDA UDI
- FDA Product Code
- KMY FDA UDINXC FDA UDIMQC FDA UDIEBG FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI872.5470 FDA UDI872.3770 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Essix ACE® by Dentsply Sirona Orthodontics 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI b275621a-965a-433a-b42b-477f1bb9263c 36 fields · synced Jun 9, 2026