Identity
- Trade Name
- Aelite LS Posterior FDA UDI
- Generic Name
- Dental composite resin kit FDA UDI
- Device Name
- Aelite LS Posterior Syringe Kit FDA UDI
- Model / Reference
- H-72110K FDA UDI
- Description
- Aelite LS Posterior Syringe Kit FDA UDI
Identifiers
- Catalog Number
- H-72110K FDA UDI
- Primary DI / UDI-DI
- D757H72110K1 FDA UDI
- FDA Product Code
- EBD FDA UDIEBF FDA UDIEMA FDA UDIEID FDA UDIKXR FDA UDI
- GMDN Term
- Dental composite resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 FDA UDI872.3690 FDA UDI872.3275 FDA UDI872.4565 FDA UDI872.3140 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 composite resin kit
Aelite LS Posterior by Bisco 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
- Bisco Inc.
Sources (1)
- FDA UDI 870a79b5-7c34-45fd-b9c7-b06342fa0b96 36 fields · synced Jun 8, 2026