Identity
- Trade Name
- Lower Anterior Pontic FDA UDI
- Generic Name
- Dental shaded pontic kit FDA UDI
- Device Name
- Lower Anterior Pontic - Gray Set of 6 FDA UDI
- Model / Reference
- ELA6-G FDA UDI
- Description
- Lower Anterior Pontic - Gray Set of 6 FDA UDI
Identifiers
- Catalog Number
- ELA6-G FDA UDI
- Primary DI / UDI-DI
- D746ELA6G1 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Dental shaded pontic kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental shaded pontic kit
Lower Anterior Pontic by Dentsply Sirona Orthodontics Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI e446841a-b41b-4c00-b1c3-7fbf608e48f5 35 fields · synced Jun 9, 2026