BTI Interna 3.0 Dental Implant System UnicCa

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K240262 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

  Class II

  FDA 510(k) K231827 Active Cleared 15 Sep 2023

• BTI Interna Prosthetic Components

  Class II

  FDA 510(k) K232750 Active Cleared 8 Dec 2023

• BTI Interna Narrow/Plus Dental Implant System UnicCa

  Class II

  CE/MDR FDA 510(k) K211952 Active Cleared 21 Jul 2022

• Bti Dental Implant Tiny 2.5-3.0

  Class II

  FDA 510(k) K092112 Active Cleared 6 Oct 2009

• BTI Extra-Short Dental Implant System UnicCa

  Class II

  FDA 510(k) K202825 Active Cleared 29 Jul 2021

• Bti Dental Implant 5.5-6.5

  Class II

  FDA 510(k) K091387 Active Cleared 22 Jan 2010

See all devices from B.T.I. Biotechnology Institute, Sl. →

• What types of dental clinics or settings is the BTI Interna 3.0 Dental Implant System UnicCa® designed for, and how does this affect its use?

  The BTI Interna 3.0 Dental Implant System UnicCa® is specifically designed for use in dental clinics and oral surgery settings, where professionals can perform procedures requiring osseointegration. This targeted design ensures compatibility with standard dental workflows, including implant placement, abutment connection, and prosthetic restoration. Its sterile, single-use nature also aligns with clinical protocols where contamination risks must be minimized, making it suitable for controlled environments like these.

• Is the BTI Interna 3.0 Dental Implant System UnicCa® reusable, or is it intended for single-use only? Why does this matter?

  The BTI Interna 3.0 Dental Implant System UnicCa® is explicitly intended for single-use only, as stated in the manufacturer’s specifications. This design choice matters because single-use implants reduce the risk of cross-contamination between patients, align with infection control protocols, and eliminate the need for sterilization between uses. Clinicians should adhere to this guideline to maintain patient safety and regulatory compliance.

• How is the BTI Interna 3.0 Dental Implant System UnicCa® supplied, and what does this mean for storage and handling?

  The system is supplied sterile, which means it is pre-packaged and ready for immediate use without additional sterilization. This requires clinicians to store it in a clean, dry environment—protected from moisture, extreme temperatures, and physical damage—until use. Proper storage ensures sterility is maintained until implantation, reducing the risk of infection or compromise to the implant’s integrity.

• What regulatory pathways does the BTI Interna 3.0 Dental Implant System UnicCa® follow, and how does this impact its availability?

  The system follows FDA 510(k) clearance under the Traditional pathway (K240262) and is also regulated under the EU Medical Device Regulation (MDR). This means it has undergone evaluation by regulatory bodies to confirm its safety and performance, ensuring compliance with both U.S. and EU standards. Clinicians in the U.S. can rely on its FDA clearance for use, while EU practitioners should verify local compliance with MDR requirements before implementation.

• Are there any special considerations for using the BTI Interna 3.0 Dental Implant System UnicCa® in patients who may require MRI scans?

  The manufacturer does not specify any MRI safety restrictions for the BTI Interna 3.0 Dental Implant System UnicCa®. However, clinicians should always confirm compatibility with their specific MRI protocols and equipment, as individual facility settings may vary. If in doubt, consulting the manufacturer or radiology team is recommended to ensure patient safety during imaging.