Identity
- Trade Name
- System B Handpiece FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Handpiece Assembly for System B FDA UDI
- Model / Reference
- 952-0008 FDA UDI
- Description
- Handpiece Assembly for System B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989068481 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic obturation system
System B Handpiece by Ormco Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic obturation system.
- EndoPilot D-Pack — Schlumbohm GmbH & Co. KG · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- Needle — B&L Biotech Co., Ltd. · Class I
- Needle — B&L Biotech Co., Ltd. · Class I
- DUO-GUN — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- DUO-PEN — DiaDent Group International · Class I
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
- Ormco Corporation
Sources (1)
- FDA UDI df6f3139-fa21-4d3c-81f8-987a775d977b 34 fields · synced Jun 9, 2026