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Bulk Fill Composite Syringe Kit
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K940030
by Bisco Inc.
Identity
- Trade Name
- Bulk Fill Composite Syringe Kit FDA UDI
- Generic Name
- Dental composite resin kit FDA UDI
- Model / Reference
- H-93010K FDA UDI
Identifiers
- Catalog Number
- H-93010K FDA UDI
- Primary DI / UDI-DI
- D757H93010K1 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
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
Bulk Fill Composite Syringe Kit by Bisco Inc. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940030 | Class I | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (2)
- FDA UDI b9339eba-9a35-4358-8ca0-206a356b19c7 61 fields · synced Jun 18, 2026
- FDA 510(k) K940030 1 fields · synced May 22, 2026