Identity
- Trade Name
- EXAlence™ FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- EXA’lence™ Dynamic Mixing Tips, 370mL (50 x mixing tips) FDA UDI
- Model / Reference
- 150004 FDA UDI
- Description
- EXA’lence™ Dynamic Mixing Tips, 370mL (50 x mixing tips) FDA UDI
Identifiers
- Catalog Number
- 150004 FDA UDI
- Primary DI / UDI-DI
- 10386040006088 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
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
No
FDA UDI
Category: Dental impression tray, single-use
EXAlence™ by Gc America Inc. — 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
- Gc America Inc.
Sources (1)
- FDA UDI b9307de0-930a-474a-8878-bafbcfbe0b12 35 fields · synced Jun 1, 2026