Identity
- Trade Name
- Endogel FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Device Name
- Endodontic Lubricating Gel: Bulk Pack of 288 tubes FDA UDI
- Model / Reference
- EG-BP FDA UDI
- Description
- Endodontic Lubricating Gel: Bulk Pack of 288 tubes FDA UDI
Identifiers
- Catalog Number
- EG-BP FDA UDI
- Primary DI / UDI-DI
- 00859611006716 FDA UDI
- 510(k) Number
- K992484 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Root canal cleaning solution FDA UDI
Classification
- Device Class
- U 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
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Root canal cleaning solution
Endogel by Jordco, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K992484 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Jordco, Inc.
Sources (1)
- FDA UDI 8225896d-4aad-4d51-8f0c-557f7e5e8398 37 fields · synced Jun 6, 2026