BTI Dental Implant System UnicCa® Aesthetic Post Abutments
K-Number: K231827 · 2023-09-15
ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2023-09-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BTI Dental Implant System UnicCa® Aesthetic Post Abutments is a medical device manufactured by B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2023-09-15 under approval number K231827. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BTI Dental Implant System UnicCa® Aesthetic Post Abutments?
BTI Dental Implant System UnicCa® Aesthetic Post Abutments is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K231827.
When was BTI Dental Implant System UnicCa® Aesthetic Post Abutments approved by the FDA?
BTI Dental Implant System UnicCa® Aesthetic Post Abutments received FDA 510(k) clearance on 2023-09-15, under approval number K231827.
What company makes BTI Dental Implant System UnicCa® Aesthetic Post Abutments?
BTI Dental Implant System UnicCa® Aesthetic Post Abutments is manufactured by B.T.I. Biotechnology Institute, Sl..
What is the FDA product code for BTI Dental Implant System UnicCa® Aesthetic Post Abutments?
The FDA product code for BTI Dental Implant System UnicCa® Aesthetic Post Abutments is NHA.
Related Clinical Trials
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
NCT06642935
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
ACTIVE_NOT_RECRUITING
NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RECRUITING
NCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
ACTIVE_NOT_RECRUITING
NCT07343141
To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 39892748
Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.
Ophthalmology (2025)
PMID: 41966145
From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".
International journal of health policy and management (2025)
PMID: 39726899
How to improve the mechanical safety of a novel spinal implant while saving costs and time.
JOR spine (2024)
Other Devices by B.T.I. Biotechnology Institute, Sl.
K151391BTI Dental Implant System UnicCa
K173257BTI Dental Implant System UnicCa
K202825BTI Extra-Short Dental Implant System UnicCa
K213106BTI Interna Dental Implant System UnicCa - Prosthetic Components
K211952BTI Interna Narrow/Plus Dental Implant System UnicCa
K232750BTI Interna Prosthetic Components
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.