Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DigiLine Direct Print Aligner System

K-Number: K233935 · 2024-04-05

ApplicantPark Dental Research Corporation
Decision Date2024-04-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DigiLine Direct Print Aligner System is a medical device manufactured by Park Dental Research Corporation. It received FDA 510(k) clearance on 2024-04-05 under approval number K233935. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DigiLine Direct Print Aligner System?

DigiLine Direct Print Aligner System is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Park Dental Research Corporation. The 510(k) number is K233935.

When was DigiLine Direct Print Aligner System approved by the FDA?

DigiLine Direct Print Aligner System received FDA 510(k) clearance on 2024-04-05, under approval number K233935.

What company makes DigiLine Direct Print Aligner System?

DigiLine Direct Print Aligner System is manufactured by Park Dental Research Corporation.

What is the FDA product code for DigiLine Direct Print Aligner System?

The FDA product code for DigiLine Direct Print Aligner System is NXC.

Related Clinical Trials

NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED

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)

Other Devices by Park Dental Research Corporation

K181220Juell 3D Volo Base K180648Park Dental Research Aligners

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

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.

↑