Identity
- Trade Name
- Endodontic Diagnostic Instrument FDA UDI
- Generic Name
- Endodontic cold test foam wedge FDA UDI
- Device Name
- e-Dx Kit Pack FDA UDI
- Model / Reference
- EDX-S FDA UDI
- Description
- e-Dx Kit Pack FDA UDI
Identifiers
- Catalog Number
- EDX-S FDA UDI
- Primary DI / UDI-DI
- 00859611006532 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Endodontic cold test foam wedge 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic cold test foam wedge
Endodontic Diagnostic Instrument by Jordco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic cold test foam wedge.
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- Endodontic Diagnostic Instrument — Jordco, Inc. · Class I
- Endodontic Diagnostic Instrument — Jordco, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Jordco, Inc.
Sources (1)
- FDA UDI 816a429a-827b-4183-9e77-0dbbd94b5003 35 fields · synced Jun 8, 2026