Identity
- Trade Name
- Bulk Fill Composite Unit Dose Kit FDA UDI
- Generic Name
- Dental composite resin kit FDA UDI
- Model / Reference
- H-93030K FDA UDI
Identifiers
- Catalog Number
- H-93030K FDA UDI
- Primary DI / UDI-DI
- D757H93030K1 FDA UDI
- FDA Product Code
- EID FDA UDIKXR FDA UDIEJK FDA UDIKLE FDA UDIEBF FDA UDI
- GMDN Term
- Dental composite resin kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.3140 FDA UDI872.3250 FDA UDI872.3200 FDA UDI872.3690 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Bulk Fill Composite Unit Dose Kit by Bisco Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI aec4ee27-2cdb-4f5e-b671-1a11dba6b94e 37 fields · synced Jun 1, 2026