Identity
- Trade Name
- Aelite All-Purpose Body FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) FDA UDI
- Model / Reference
- H-814A35 FDA UDI
- Description
- Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) FDA UDI
Identifiers
- Catalog Number
- H-814A35 FDA UDI
- Primary DI / UDI-DI
- 10810111541784 FDA UDI
- 510(k) Number
- K982729 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Aelite All-Purpose Body by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K982729 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI c94f3dbe-cd1d-42a0-978b-5cc13102cc0c 37 fields · synced May 30, 2026