(36 days)
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No
The summary describes a standard dental handpiece and explicitly states the technology, design, manufacturing, and materials are substantially equivalent to existing devices, with no mention of AI or ML.
No.
The device is used for drilling and preparation, which are procedural steps in a dental restoration process, rather than directly treating a disease or condition itself.
No
Explanation: The device is a high-speed dental handpiece used for drilling and preparation, which are therapeutic and restorative procedures, not diagnostic ones.
No
The device description explicitly states it is a "High speed dental handpiece," which is a physical hardware device used for drilling. The summary does not mention any software component as the primary or sole function.
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 for restoration, such as fillings," which is a direct intervention on the patient's body (intraorally).
- Device Description: The description reinforces its use as a tool for physical manipulation within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a therapeutic/restorative procedure.
N/A
Intended Use / Indications for Use
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate.
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.
Star Dental 430 Series High Speed Handpiece
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
STAR DENTAL HIGH SPEED HANDPIECE 9600719
510(k) Summary
Company:
Star Dental, Division of Den-Tal-Ez, Inc. Owner/operator number 2520265
KRG0719
Contact Person:
MAR 28 1996
Jeff Peinhardt Quality Assurance Manager Star Dental, Division of Den-Tal-Ez, Inc. 1816 Colonial Village Ln. Lancaster, PA 17601 (717) 291-1161 Phone (717) 291-3249 Fax
Device Trade Name:
430 Series High Speed Handpiece
Common or Usual Name:
High Speed Handpiece
Predicate Device:
Star Dental 430 Series High Speed Handpiece
Intended Use/Description:
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate. The technology, design, manufacturing, and materials are substantially equivalent to those of other handpieces on the market, including that of the current 430 series handpiece.
Substantial Equivalence:
The determination of substantial equivalence is based on the fact that the proposed Star Dental device and the predicate Star Dental device utilize substantially equivalent intended use, technology, design, manufacturing, and materials and so will be substantially equivalent in clinical performance.