SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING - 45301. Rd Ceramic Coping For Quick Abutment
510(k) K060530
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060530 | Date22 May 2006 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- ELL
- Models / Variants
- 45301. Rd Ceramic Coping For Quick Abutment
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3920
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SD and RD Ceramic Coping for Quick Abutment, Locking are dental components designed to fit over dental abutments, providing a ceramic coping layer for crown or bridge restorations. These components are intended to enhance the fit and stability of prosthetic dental work while maintaining aesthetic and functional integrity in the oral environment.
These ceramic copings are supplied as single-use items for dental laboratories and clinicians, intended for use with compatible Keystone/Lifecore abutment systems. They are classified as Class II devices under FDA regulations and have received 510(k) clearance for dental applications. Storage and handling follow standard dental laboratory protocols to preserve sterility and structural integrity prior to use.
Other devices from Lifecore Biomedical, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these ceramic copings designed for reuse in multiple dental procedures, or are they intended as single-use items?
These SD and RD Ceramic Copings (Models 45301 and 45302) are explicitly supplied as single-use items for dental laboratories and clinicians. The manufacturer’s description emphasizes their intended use in a single procedure to ensure sterility and structural integrity, aligning with standard dental laboratory protocols.
What types of dental abutments are these ceramic copings compatible with, and how do they improve prosthetic stability?
The SD and RD Ceramic Copings are designed to fit over compatible Keystone/Lifecore abutment systems, providing a ceramic layer for crown or bridge restorations. Their locking mechanism enhances fit and stability, ensuring the prosthetic work remains secure while maintaining aesthetic and functional integrity in the oral environment.
How should these ceramic copings be stored to maintain their sterility and structural integrity before use?
Storage and handling follow standard dental laboratory protocols to preserve sterility and structural integrity. Since they are single-use items, they should be kept in a clean, dry environment—protected from moisture, contamination, or physical damage—until ready for use in a controlled clinical or lab setting.
What distinguishes the SD (Model 45301) and RD (Model 45302) ceramic copings from each other?
The data provided does not specify technical differences between the SD (Model 45301) and RD (Model 45302) ceramic copings beyond their distinct model numbers. Both are described as ceramic copings for locking Quick Abutments, intended for crown/bridge restorations. Clarification on specific design variations (e.g., size, material composition, or fit) would require additional manufacturer documentation.