Identity
- Trade Name
- RE-GEN Bioactive EndoPutty Kit FDA UDI
- Generic Name
- Root canal obturation kit FDA UDI
- Model / Reference
- 504756 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207024913 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Root canal obturation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
No
FDA UDI
Category: Root canal obturation kit
RE-GEN Bioactive EndoPutty Kit by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Root canal obturation kit.
- Endo@pex — DXM CO., LTD · Class I
- EndoCeramic Sealer — ENDO DIRECT, LLC · Class II
- Gutta Easy — DXM CO., LTD · Class I
- EndoCeramic Root Repair Material — ENDO DIRECT, LLC · Class II
- Friendo — DXM CO., LTD · Class I
- RE-GEN Bioactive EndoSealer — Vista Dental · Class II
- REGEN Bioactive EndoSealer (SS MST Kit) — Vista 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
- Vista Dental
Sources (1)
- FDA UDI 4eff2bb3-4f20-4a9a-ba8c-f6d4bb03d667 34 fields · synced Jun 6, 2026