(70 days)
Star Dental TITAN Series Motors and Attachments, Micro Motors, Nakinishi Dental, KAVO, Lares low speed motors
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No
The summary describes a simple air-powered dental motor with no mention of AI/ML capabilities or related data/performance metrics.
No
This device is a dental motor used to power various attachments and accessories for routine dental procedures, primarily facilitating the clinician's work rather than directly providing a therapeutic effect to a patient.
No
The device is described as an "Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures." Its function is to facilitate procedures, not to diagnose conditions.
No
The device description explicitly states it is an "Air powered low speed dental motor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to power dental attachments and accessories for routine dental procedures. This involves mechanical action within the mouth, not the examination of specimens derived from the human body.
- Device Description: The description reinforces the mechanical nature of the device as an air-powered motor.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This dental motor does not fit that description.
N/A
Intended Use / Indications for Use
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
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
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Indicated Patient Age Range
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Intended User / Care Setting
dental clinician
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 TITAN Series Motors and Attachments, Micro Motors, Nakinishi Dental, KAVO, and Lares low speed motors.
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
K9C6XC
510(K) SUMMARY STAR DENTAL LOW SPEED MOTORS AND ATTACHMENTS
Company:
1
Star Dental, Division of Den-Tal-Ez, Inc. Owner/operator number 2520265
MAR 28 1996
Contact Person:
Jeff Peinhardt Quality Assurance Manager Star Dental, Division of Den-Tal-Ez, Inc. 1816 Colonial Village Ln. Lancaster, PA 17601 Phone (717) 291-1161 (717) 291-3249 Fax
Device Trade Name:
Star Dental TITAN Series Motors and Attachments
Common or Usual Name:
Low Speed Motors and Attachments
Predicate Devices:
Star Dental TITAN Series Motors and Attachments, Micro Motors, Nakinishi Dental, KAVO, and Lares low speed motors.
Description/Intended Use:
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
Substantial Equivalence:
The Low Speed air-powered motor as submitted is substantially equivalent to other motors currently being marketed by, Micro Motors, Nakinishi Dental, KAVO, and Lares. Materials used to manufacture the components are similar. Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power for various dental procedures. The performance specifications are virtually identical. The differentiation between the predicate device and the submitted one is more precise speed control, spring pre-loaded bearings.