Dental Endodontic Cement (Modification)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K894092 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dental Endodontic Cement (Modification) is a resin-based root canal filling device classified under the medical specialty of Dental. It is identified by the device name and product code KIF, and is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.
The device received FDA 510(k) clearance K894092 on January 10, 1990, following submission on June 8, 1989. It is regulated under regulation number 872.3820, classified as Class II, and was cleared via the traditional pathway without third-party review. The manufacturer is The Hygenic Corp., located in Akron, Ohio.
Frequently asked questions
What is Dental Endodontic Cement (Modification) used for?
Dental Endodontic Cement (Modification) is a resin-based device used as a root canal filling material in dental endodontic procedures to seal and obturate the cleaned and shaped root canal system.
How is Dental Endodontic Cement (Modification) supplied and is it sterile?
The device data does not specify the supply format or sterility status of Dental Endodontic Cement (Modification); users should refer to the manufacturer's labeling for details on packaging, sterility, and handling instructions.
Is Dental Endodontic Cement (Modification) intended for single-use or reuse?
The device data does not indicate whether Dental Endodontic Cement (Modification) is designed for single-use or reuse; clinicians must consult the manufacturer's instructions for use to determine appropriate application and disposal practices.
What regulatory pathway was used for Dental Endodontic Cement (Modification)?
Dental Endodontic Cement (Modification) received FDA 510(k) clearance through the traditional pathway, as indicated by the clearance_type field, and was found substantially equivalent to a predicate device without third-party review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DENTAL ENDODONTIC CEMENT (MODIFICATION) (K894092) — FDA 510 (k ..., DENTAL ENDODONTIC CEMENT (MODIFICATION) 510(k) K894092 - fda.report, The Hygenic Corp. FDA 510 (k) Products (1979-1996)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894092 | Class II | Active |
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Manufacturer
- Manufacturer
- The Hygenic Corp.
Sources (1)
- FDA 510(k) K894092 24 fields · synced Oct 1, 2026