EndoREZ Root Canal Filling Resin
by Ultradent Products, Inc. 2 variants
510(k) K042756
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042756 | Date26 Oct 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Endorez
- 510(k) Number
- FDA Product Code
- KIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
EndoREZ is a Resin, Root Canal Filling (per FDA classification) designed to seal root canal systems during endodontic therapy. This hydrophilic, self-priming material adheres to dentinal tubules and lateral canals, providing a complete seal to prevent microbial leakage and promote long-term success of root canal treatments. Its thixotropic properties ensure precise application within the canal space, minimizing voids and enhancing restoration integrity.
The device is supplied as a single-use, non-sterile resin sealer intended for professional dental use. It requires mixing and application by a clinician in a controlled setting, with no MRI safety restrictions noted. Available in standard packaging, it must be stored according to manufacturer instructions to maintain efficacy. Authorized under FDA 510K clearance (K042756), it adheres to dental regulatory standards for root canal sealers under regulation number 872.3820.
Other devices from Ultradent Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is EndoREZ used for in endodontic therapy?
EndoREZ is a resin-based root canal sealer designed to create a complete seal within the root canal system during endodontic treatment. Its hydrophilic properties allow it to adhere strongly to dentinal tubules and lateral canals, minimizing gaps and preventing microbial leakage. This helps ensure the long-term success of root canal procedures by maintaining a stable, hermetic seal.
How is EndoREZ supplied and prepared for use?
EndoREZ is supplied as a single-use, non-sterile resin sealer intended exclusively for professional dental use. It requires mixing by a clinician in a controlled setting before application. The thixotropic properties of the material enable precise placement within the canal space, reducing the risk of voids and improving restoration integrity.
Is EndoREZ sterile or reusable?
EndoREZ is supplied in a non-sterile form and is intended for single-use only. It must be mixed and applied by a clinician in a sterile environment to maintain infection control standards. Reuse is not recommended or supported by the manufacturer.
What storage conditions are required for EndoREZ?
EndoREZ must be stored according to the manufacturer’s instructions to preserve its efficacy. Proper storage typically involves keeping the product in a cool, dry place, away from direct sunlight or extreme temperatures. Always refer to the packaging for specific storage guidelines to ensure optimal performance and shelf life.
Does EndoREZ have any MRI safety restrictions?
No MRI safety restrictions are noted for EndoREZ. However, as with any dental material used in the oral cavity, clinicians should follow standard protocols for patient safety during imaging procedures. Always verify compatibility with any specific MRI system or protocol in use.