Identity
- Trade Name
- AELITE- A.P.Body A3.5O Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Model / Reference
- H-812A35O FDA UDI
Identifiers
- Catalog Number
- H-812A35O FDA UDI
- Primary DI / UDI-DI
- D757H812A35O0 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
- Not 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
No
FDA UDI
AELITE- A.P.Body A3.5O Syringe by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K982729 also covers:
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
- Aelite All-Purpose Body — BISCO INC.
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 2b2ead4f-a867-4d2d-a777-115c06359c5a 38 fields · synced Jun 8, 2026