Nucleoss Tpure Implant System
by Sanlilar Tibbi Cihazlar Med. Kim. San. Tic. Ltd. Sti
510(k) K160850
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK160850 | Date4 Aug 2017 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DZE
- FDA applicant
- Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Nucleoss Tpure Implant System is a dental implant device designed for osseointegration within the alveolar bone, providing a foundation for prosthetic teeth. It is classified under dental implant systems and incorporates advanced surface technology to enhance biocompatibility and integration with surrounding tissues.
This system is supplied as a sterile, single-use implant intended for use in oral and maxillofacial surgery settings. It is regulated under the FDA 510(k) pathway with a clearance type designated as Traditional (K160850) and is also compliant with the EU Medical Device Directive (MDD). The product is available in various sizes and configurations as specified in the device’s technical documentation.
From the manufacturer
NucleOSS manufactures reliable dental implant systems with advanced surface technology and innovative design — innovative implant solutions for dental professionals.
NucleOSS, ileri yüzey teknolojisi ve yenilikçi tasarımıyla güvenilir dental implant sistemleri üretir — diş hekimleri için yenilikçi implant çözümleri.
Other devices from Sanlilar Tibbi Cihazlar Med. Kim. San. Tic. Ltd. Sti
Questions
AI-generated answers, 18 Sep 2026
What types of dental procedures is the Nucleoss Tpure Implant System designed for, and how does its surface technology help in those procedures?
The Nucleoss Tpure Implant System is specifically designed for osseointegration within the alveolar bone, serving as a foundation for prosthetic teeth in oral and maxillofacial surgeries. Its advanced surface technology enhances biocompatibility and integration with surrounding tissues, which improves stability and long-term success of the implant by promoting stronger bonding with the bone.
Is the Nucleoss Tpure Implant System intended for reuse, or is it meant to be used only once per patient?
The Nucleoss Tpure Implant System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining the integrity of the implant’s biocompatible surface, which is critical for successful osseointegration.
What size and configuration options are available for the Nucleoss Tpure Implant System, and how might this affect my choice for a patient?
The Nucleoss Tpure Implant System comes in various sizes and configurations, as detailed in its technical documentation. These variations allow for customization based on the patient’s anatomical structure, bone density, and specific clinical needs, ensuring a tailored fit for optimal prosthetic support and long-term stability.
How should the Nucleoss Tpure Implant System be stored to maintain its sterility and performance?
Since the Nucleoss Tpure Implant System is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight and extreme temperatures. Proper storage ensures the implant remains uncontaminated and ready for immediate use when needed, preserving its biocompatibility and structural integrity.
What regulatory pathways does the Nucleoss Tpure Implant System follow, and how does this affect its availability in different markets?
The Nucleoss Tpure Implant System has been cleared through the FDA’s 510(k) pathway (Traditional, K160850) and is compliant with the EU Medical Device Directive (MDD). This dual regulatory approval allows the device to be legally marketed in both the United States and the European Economic Area, ensuring broader accessibility for clinicians and patients in those regions.