The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation. The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodentic applications to prepare the tooth and/or root of the tooth for repair.

Device Description

Four different types of tips will be manufactured by San Diego Swiss Machining as follows: Scaler Tips, Plugger Tips, Cutting Tips, Spreader Tips. The tips have been designed with an assortment of bends and/or angles to allow greater flexibility during debridment, cleansing, irrigation, disinfection, canal shaping and other various endodontic applications. The tips will be made of 13-8 stainless steel and coated with titanium nitride and/or zirconium nitride mater als.

AI/ML Overview

This 510(k) summary for the Sapphire Plus® Tips (K960889) indicates that no performance data, nonclinical data, or clinical data were submitted.

Therefore, there is no information provided in this document regarding acceptance criteria or a study demonstrating the device meets such criteria.

The submission relies solely on a Statement of Substantial Equivalence to existing FDA-cleared devices, meaning the manufacturer asserts their device is as safe and effective as previously approved devices based on similarities in intended use, composition, and operational principles.

For a complete answer, here's a breakdown of the requested information, highlighting what is not available in this document:

A table of acceptance criteria and the reported device performance:
- Not Available. No acceptance criteria or performance data are provided.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. No test set or associated data are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Available. No ground truth establishment or experts are mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available. No test set or adjudication method are mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable/Not Available. This device is an ultrasonic dental tip, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available. This device is an ultrasonic dental tip, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available. No ground truth is mentioned.
The sample size for the training set:
- Not Available. No training set is mentioned.
How the ground truth for the training set was established:
- Not Available. No training set or ground truth establishment are mentioned.

Summary

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K960889

MAY 1 0 1996

XIII. 510(k) SUMMARY [807.92(c)]

Applicant name:

San Diego Swiss Machining 990 Lane Avenue, Suite 1.20 Chula Vista, CA 91914 (619) 421-9955 (619) 421-9949 (fax)

Contact Person: Teresa Hickok, President Date Summary Prepared: February 29, 1996

DEVICE NAME

Trade Name:	Sapphire Plus® Tips
Common Name:	Ultrasonic files
Classification Name:	Ultrasonic Scaler, Accessories

THE PRODUCT AND ITS INTENDED USE

The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodentic applications to prepare the tooth and/or root of the tooth for repair.

Four different types of tips will be manufactured by San Diego Swiss Machining as follows:

Scaler Tips Plugger Tips Cutting Tips Spreader Tips

The tips have been designed with an assortment of bends and/or angles to allow greater flexibility during debridment, cleansing, irrigation, disinfection, canal shaping and other various endodontic applications. The tips will be made of 13-8 stainless steel and coated with titanium nitride and/or zirconium nitride mater als.

Premarket Notification Submission	Sapphire Plus® Tips
San Diego Swiss Machining	Page 25

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STATEMENT OF SUBSTANTIAL EQUIVALENCE

The San Diego Swiss Machining considers the Sapphire Plus® Tips to be substantially equivalent to FDA-cleared, as depicted in Table #1.

	San DiegoSwissMachining	EMS	Spartan USA	EIE	Amadent	DentsplyCavitron
DeviceName	Sapphire(R)Plus Tips	Piezon Master400Ultrasonic Tips	Piezo-ElectricScalersModels J-3 and S-3	UltrasonicTips	Neosonics-D	EndosonicFiles
Composition	StainlessSteel	Stainless Steel	Stainless Steel	StainlessSteel	StainlessSteel	StainlessSteel
IntendedUse	Reconstructive dentalprocedures,crown prep,periodonticprep. proc.,tissuescaling, rootprep.	Reconstructivedentalprocedures(crown prep.),periodonticprep. proc.,tissue scaling,root prep.	Reconstructivedentalprocedures (crownprep.),periodontic prep.proc.,tissue scaling, rootprep.	Endodonticrootprep	Tooth andsub-gingivalscalingand rootplaning	Canaldebride-ment,cleansing,canalshaping
OperationalPrinciples	UltrasonicEnergy	UltrasonicEnergy	UltrasonicEnergy	UltrasonicEnergy	UltrasonicEnergy	UltrasonicEnergy
Coating(s)	TitaniumNitrideZirconiumNitride	None	None	None	Diamond(Tips)	None

TABLE #1 --SUMMARY OF SUESTANTIAL EQUIVALENCY

Performance Data: N/A

Nonclinical Data: N/A

Clinical Data: N/A

-- END OF 510(k) SUMMARY -

Premarket Notification Submission	The support of the control of the control of the comment of the comments of the comments of the comments of the comments of the comments of the contribution of the comments oSapphire Plus® Tips
San Diego Swiss MachiningComments of the contract and consisted to the control controllers and any and	Page 26

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.