CEMENTABLE ABUNTMENTS - Temporary Copings
510(k) K080286
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080286 | Date7 Mar 2008 | 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- Withdrawn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
- NHA
- Models / Variants
- Temporary Copings
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device comprises cementable abutments, temporary copings, and protective caps for dental implants, designed to facilitate prosthetic restoration. The abutments are intended to be permanently affixed to dental implants via cement, providing a stable foundation for crowns or other dental prosthetics. Temporary copings serve as interim restorations, ensuring proper fit and function during the final restoration process, while protective caps safeguard the abutment during fabrication of definitive restorations. These components are part of the Straumann P.004 NC system, adhering to dental implant protocols for precision and stability.
The device is supplied as a set of reusable, non-sterile components intended for use in dental offices or clinics. Temporary copings are available in specific diameters (e.g., Ø 5mm, Ø 6.5mm) and manufactured from polymethyl methacrylate (PMMA). Sterilization is performed by the practitioner prior to use, typically via autoclave or chemical disinfection. Compliance with FDA 510(k) clearance (K080286) and classification under product code NHA (Dental Abutments) ensures adherence to regulatory standards for dental implant components. No MRI safety considerations are specified, and storage should follow manufacturer guidelines for dental implant accessories.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What are Straumann P.004 NC cementable abutments used for?
The Straumann P.004 NC cementable abutments are designed to provide a stable foundation for dental crowns or other prosthetics by being permanently affixed to dental implants via cement. They are part of a system that supports both definitive restorations and interim solutions, ensuring proper fit and function during the final restoration process.
Are the temporary copings single-use or reusable?
The temporary copings included in this set are reusable components. They are manufactured from polymethyl methacrylate (PMMA) and are intended to be used multiple times in dental offices or clinics, provided they are properly sterilized between uses.
How should the components be sterilized before use?
The components are non-sterile and must be sterilized by the practitioner prior to use. Common sterilization methods include autoclaving or chemical disinfection, following standard dental office protocols to ensure safety and efficacy.
What diameters are available for the temporary copings?
The temporary copings in this set are available in specific diameters, including Ø 5mm and Ø 6.5mm, to accommodate different patient needs and implant sizes.
What storage guidelines should be followed for these components?
Storage should adhere to the manufacturer’s guidelines for dental implant accessories. Ensure components are kept in a clean, dry environment, protected from contamination, and follow any additional recommendations provided by Straumann to maintain their integrity and functionality.