Identity
- Trade Name
- System B FDA UDI
- Generic Name
- Endodontic filling material condenser FDA UDI
- Device Name
- Heat Source, Model 1005 FDA UDI
- Model / Reference
- 952-0001 FDA UDI
- Description
- Heat Source, Model 1005 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989068412 FDA UDI
- FDA Product Code
- EAT FDA UDI
- GMDN Term
- Endodontic filling material condenser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1720 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling material condenser
System B by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
Sources (1)
- FDA UDI 22848677-4e69-4601-89be-b432ade5b9ef 35 fields · synced Jun 9, 2026