Identity
- Trade Name
- INTRAORAL REPAIR KIT FDA UDI
- Generic Name
- Dental composite resin kit FDA UDI
- Model / Reference
- B-22300K FDA UDI
Identifiers
- Catalog Number
- B-22300K FDA UDI
- Primary DI / UDI-DI
- 00810111542494 FDA UDI
- FDA Product Code
- EBC FDA UDIEID FDA UDIKXR FDA UDI
- GMDN Term
- Dental composite resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 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
Intraoral Repair Kit by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin kit.
- Hexa — Hexa Dental · Class II
- AxioComp NT — Axiodent Inc. · Class II
- Hexa — Hexa Dental · Class II
- PANAVIA™ V5 — KURARAY NORITAKE DENTAL INC. · Class II
- Hexa — Hexa Dental · Class II
- Rocatec™ Plus — 3M Deutschland GmbH · Class II
- PANAVIA™ V5 — KURARAY NORITAKE DENTAL INC. · Class II
- Hexa — Hexa Dental · Class II
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 7839e96c-bd63-4180-8587-ec70f2519f59 35 fields · synced May 29, 2026