Identity
- Trade Name
- AURA FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Model / Reference
- AURA 20 COMP MC2 FDA UDI
Identifiers
- Catalog Number
- 8565014 FDA UDI
- Primary DI / UDI-DI
- DO3685650141 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental pit/fissure sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental pit/fissure sealant
Aura by Sdi , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pit/fissure sealant.
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- SciPharm Pit & Fissure Sealer Bonding Agent, Part A — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class II
- MASTER-DENT — DENTONICS, INC.
- SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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
- Sdi , Ltd.
Sources (1)
- FDA UDI f39f5cc7-a139-43f4-aeb2-0a3d8ce6c3cb 35 fields · synced Jun 1, 2026