(52 days)
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No
The summary describes a mechanical component (turbine) for a dental handpiece and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is a component of a high-speed handpiece used for drilling and preparation, which are interventional procedures, but the device itself does not directly provide therapy or treatment for a disease or condition. It is a tool for a procedure, not a therapeutic agent.
No.
The device is a component of a high-speed handpiece used for drilling and preparation of dental cavities, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "Replacement Turbine," which is a hardware component of a dental handpiece. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for drilling and preparation of dental cavities intraorally. This is a direct interaction with the patient's body for a therapeutic or procedural purpose.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The description clearly indicates the device is a component of a dental handpiece used inside the mouth, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intraorally
Indicated Patient Age Range
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Intended User / Care Setting
trained dental professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Midwest Quiet-Air and Tradition model handpieces. Star Dental 430 series pushbutton autochuck turbine
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
510(K) SUMMARY FOR STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE
Company:
Star Dental, Division of Den-Tal-Ez, Inc.
Contact Person:
Jeff Peinhardt Quality Assurance Manager Star Dental 1816 Colonial Village Ln. Lancaster, PA 17601
Phone (717) 291-1161 (717) 291-3249 Fax
Device Trade Name:
Star Dental Pushbutton Autochuck Replacement Turbine.
Common or Usual Name:
Replacement Turbine
Predicate Device(s):
Midwest Quiet-Air and Tradition model handpieces. Star Dental 430 series pushbutton autochuck turbine
Description/Intended Use:
Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Substantial Equivalence:
Both the predicate and the proposed Star Dental replacement turbines utilize the same technology, similar turbine design, manufacturing practices and materials. Substantial equivalence is achieved based on similarity in design and intended use.