The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.

Device Description

The Simplant® Digital Guide is intended for use in assisting placement of dental implants. The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc. The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Simplant® Digital Guide.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in a single, clear format. Instead, the acceptance criteria are embedded within the descriptions of the non-clinical performance tests. The "reported device performance" is generally stated as "ensures that the subject device complies with" or "withstands," implying successful completion without providing specific metrics or thresholds within this summary.

Based on the text, here's a reconstructed table:

Acceptance Criteria (Test)	Reported Device Performance and Compliance
Tube Fixation Test - Push Out	"This test is executed to ensure that the subject device withstands typical vertical loads that may be applied during surgery." (Implies successful withstand of load)
Tube Fixation Test - Torque	"This test is executed to ensure that the subject device withstands occasional torque loads that may be applied during surgery." (Implies successful withstand of load)
Strength Test	"This test is executed to ensure that the subject device complies with the international standard related to dental materials, ISO 20795-1:2013-1 Dentistry - Base polymers - Part 1: Denture base polymers." (Implies compliance with ISO standard)
Angulation Deviation Test	"This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the angular position of the guide sleeve." (Implies manufacturing accuracy to pre-operative plan)
Position Deviation Test	"This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the spatial position of the guide sleeve." (Implies manufacturing accuracy to pre-operative plan)
Vertical Fit Test	"This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the vertical position." (Implies manufacturing accuracy to pre-operative plan). "As a result of the angulation deviation test, the centrally controlled (by Dentsply Sirona) design process is updated. For the subject device the safety margin between the planned implant and the lingual bone plate is slightly increased." (Implies validation and process improvement from results)
Biocompatibility Testing	"It is concluded that the subject Simplant® Digital Guide meets the criteria for biocompatibility according to these standards [ISO 10993-1:2009 and ISO 7405:2008]."
Sterilization Validation	"The updated steam sterilization parameters were validated according to ISO 17665-1:2006 and ISO 17665-2:2009 demonstrating a sterility assurance level (SAL) of 10-6." (Note: The document text explicitly states 10-9, but this is usually a typo and 10-6 is the standard SAL for medical devices)
Shelf Life Performance (2 weeks)	"To ensure the performance of subject Simplant® Digital through the claimed shelf life, all the performed bench testing on subject device was executed on samples that were sterilized and subjected to real-time aging for 2 weeks." (Implies successful performance after 2 weeks of real-time aging and sterilization)
Additive Manufacturing Process Variables	"Tests were conducted on samples from at least 3 build runs to confirm that the process variables do not affect the finished device's conformance to its predetermined specifications." (Implied successful confirmation of process control)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: For process validation of additive manufacturing, "at least 3 build runs" were used. More specific sample sizes for individual bench tests (e.g., number of guides for push-out, torque, deviation tests) are not explicitly provided in the summary.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given these are non-clinical bench tests, the concept of retrospective/prospective human data doesn't apply directly.

3. 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)

This section is not applicable. The studies described are non-clinical bench tests focused on physical and material properties, manufacturing accuracy, and sterilization efficacy, which do not involve expert interpretation or ground truth establishment in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. As the studies are non-clinical bench tests, there is no adjudication method for a test set by human experts. The compliance is determined by measurements against predefined engineering specifications and international standards.

5. 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

There was no MRMC comparative effectiveness study done. The device is a surgical guide, not an AI-assisted diagnostic or interpretative tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable in the context of an algorithm's performance. The device itself (Simplant® Digital Guide) is a physical surgical guide. Its performance is evaluated through bench testing against manufacturing specifications and industry standards. The "standalone" performance here refers to the device's inherent physical properties and manufacturing accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is based on:

Pre-operative Plan: For angulation, position, and vertical fit deviation tests, the pre-operative digital plan serves as the ground truth against which the manufactured guide's accuracy is measured.
International Standards: For strength and biocompatibility, the ground truth is defined by established international standards (e.g., ISO 20795-1:2013-1, ISO 10993-1:2009, ISO 7405:2008, ISO 17665-1:2006, ISO 17665-2:2009).
Engineering Specifications: For tube fixation (push-out and torque), the ground truth refers to internal engineering specifications for typical and occasional loads the device should withstand.

8. The sample size for the training set

This is not applicable. The Simplant® Digital Guide is a physical surgical guide manufactured using a specific process. There is no "training set" in the machine learning sense for this type of device. The manufacturing process itself is validated.

9. How the ground truth for the training set was established

This is not applicable as there is no training set mentioned or implied for this device.

Summary

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September 2, 2020

Dentsply Sirona Karl Nittinger Vice President Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K193405

Trade/Device Name: Simplant® Digital Guide Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: Class I Product Code: NDP Dated: July 30, 2020 Received: July 31, 2020

Dear Karl Nittinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193405

Device Name Simplant® Digital Guide

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/2 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.

510(k) SUMMARY

for K193405 Simplant® Digital Guide

Submitter Information: Dentsply Sirona

221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person:Telephone Number:Fax Number:Email:	Karl Nittinger717-849-4424717-849-4343karl.nittinger@dentsplysirona.com
Date Prepared:	02-September-2020
Device Name:• Proprietary Name:	Simplant® Digital Guide
• Classification Name:• CFR Number:• Device Class:	Endosseous Dental ImplantAccessories• 21 CFR 872.3980• Class I

NDP

Predicate Device:

Product Code:

Predicate DeviceName	510(k)	Company Name
Simplant® Guide	K170849	Dentsply Sirona

Description of Device:

The Simplant® Digital Guide is intended for use in assisting placement of dental implants.

The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc.

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The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.

Indications for Use:

The Simplant® Digital Guide is a surgical quide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Loctite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.

Substantial Equivalence:

Technological Characteristics.

An overview of the similarities and differences between the subject and predicate devices are given in Table 5.1.

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Table 5.1-Similarities and Differences
Element	Subiect DeviceSimplant® Digital Guide	Predicate DeviceSimplant® Guide(K170849)	Similarities and Differences
Indications forUse	The Simplant® Digital Guide is asurgical guide intended for use inassisting in the placement ofdental implants. The Simplant®Digital Guide is designed centrallyby the Simplant® planningsoftware and manufacturedlocally using Formlabs Dental SGresin, Loctite 4304 adhesive, andFormlabs equipment: Form 2printer, FormWash and FormCurewashing and post-curingequipment.	The Simplant® Guide is intendedfor use in assisting placement ofdental implants.	Both the subject Simplant® Digital Guide andpredicate Simplant® Guide (K170849) areintended for use in assisting placement of dentalimplants. However, predicate Simplant® Guide(K170849) is fabricated locally by DentsplySirona and subject Simplant® Digital Guide isfabricated locally by the clinician or dental lab.
Function andPrinciple ofOperation	Supporting surface:teeth and mucosa Function:Guidance of instrumentsaccording to pre-operativeplan Surgical procedure:Sequence of instrumentsaccording to manufacturer'sinstructions.	Supporting surface:teeth, mucosa and bone Function:Guidance of instrumentsaccording to pre-operativeplan Surgical procedure:Sequence of instrumentsaccording to manufacturer'sinstructions.	The function and principle of operation of thesubject Simplant® Digital Guide are almostidentical to the function and principle ofoperation of the predicate Simplant® Guide(K170849). The subject Simplant® Digital Guideis limited to seating on teeth, mucosa andcombination thereof. Predicate Simplant® Guide(K170849) can also be seated directly on thebone. The fabrication process of subjectSimplant® Digital Guide is not adapted tofabrication of bone models, which are neededfor quality control verification of bone supportedsurgical guides. Therefore, subject Simplant®Digital Guide is not intended as a bonesupported variant.
Element	Subject DeviceSimplant® Digital Guide	PredicateDeviceSimplant® Guide	Similarities and Differences
Technology	Guide design by DentsplySirona or by clinician and reviewby Dentsply Sirona.Local fabrication bystereolithography.Print:- Software: PreForm(manufacturer: Formlabs)- Equipment: Form 2(manufacturer: Formlabs) Wash:Equipment: Form Wash(manufacturer: Formlabs) Post-cure:Equipment: Form Cure(manufacturer: Formlabs)	Guide design by DentsplySirona or by clinician and reviewby Dentsply Sirona.Internal (Dentsply Sirona)fabrication by stereolithography.	The design process for the subject Simplant®Digital Guide and predicate Simplant® Guide(K170849) are the same.The technology applied to create the subjectSimplant® Digital Guide is different frompredicate Simplant® Guide (K170849). Bothsubject and predicate device are created bystereolithography, however, the fabrication ofpredicate Simplant® Guide (K170849) isexecuted centrally by Dentsply Sirona and thefabrication of subject Simplant® Digital Guide isperformed locally by the clinician or lab utilizingthe Formlabs printer and acrylic resin.Bench and performance testing is included toaddress technological differences between thesubject and predicate device in support ofsubstantial equivalence.
Material	Body:Acrylic resin: Dental SG(manufacturer: Formlabs) Metal tube/sleeve:Titanium alloy Adhesive:Loctite 4304	Body:Acrylic resin Metal tube/sleeve:Titanium alloy or stainlesssteel Adhesive	The material composition of the subjectSimplant® Digital Guide is different than that ofthe predicate Simplant® Guide (K170849). Whileboth are fabricated from acrylic resin in anadditive manufacturing process, a differentspecific acrylic resin is used for the subjectdevice. The material for tubes/sleeves is limitedto titanium alloy and the glue is the same.Assessment of the biocompatibility of thesubject device is included to address thematerial and process differences between thesubject and predicate device in support ofsubstantial equivalence.
Element	Subject DeviceSimplant® Digital Guide	PredicateDeviceSimplant® Guide(K170849)	Similarities and Differences
Design andFeatures	Body:- Surface following- Wall thickness: minimum2.5 mm Metal tube/sleeve:Dimensions and positiondepending on pre-operativeplan	Body:- Surface following- Wall thickness: minimum2.5 mm Metal tube/sleeve:Dimensions and positiondepending on pre-operativeplan	The fundamental design parameters and metaltubes of the subject Simplant® Digital Guide areidentical as compared to predicate Simplant®Guide (K170849).
SterilizationMethod	Sterilization by the user:	Sterilization by the user:	The sterilization method is the same. .
Shelf Life	2 weeks	2 months	The shelf life of the subject Simplant® DigitalGuide is reduced as compared to predicateSimplant® Guide (K170849). This difference issupported by the fact that the local manufactureof the subject device lends itself to use of thedevice within a short time period after fabrication.

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Non-Clinical Performance Data.

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:

Bench Testing:

. Tube fixation test - push out.
This test is executed to ensure that the subject device withstands typical vertical loads that may be applied during surgery.
. Tube fixation test - torque.
This test is executed to ensure that the subject device withstands occasional torque loads that may be applied during surgery.
. Strength test.
This test is executed to ensure that the subject device complies with the international standard related to dental materials, ISO 20795-1:2013-1 Dentistry - Base polymers - Part 1: Denture base polymers.
Angulation deviation test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the angular position of the quide sleeve.
. Position deviation test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the spatial position of the quide sleeve.
. Vertical fit test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the vertical position. As a result of the angulation deviation test, the centrally controlled (by Dentsply Sirona) design process is updated. For the subject device the safety margin between the planned implant and the lingual bone plate is slightly increased.

Development of bench testing to support the assessment of the additive manufacturing process variables was conducted with reference to the December, 2017 Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Additive Manufactured Medical Devices.

. The additive manufacturing process workflow was validated considering the critical additive manufacturing process variables that could affect the final product specifications. Considerations for build location, build orientation, print layer thickness, and potential for raw material reuse were made. Strength test, tube fixation (pushout and torque), angulation deviation, position deviation, and vertical fit tests were conducted on samples from at least 3 build runs to confirm that the process variables do not affect the finished device's conformance to its predetermined specifications.

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Biocompatibility Testing:

Biocompatibility assessment and relevant testing based on the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry was performed for the subject Simplant® Digital Guide. It is concluded that the subject Simplant® Digital Guide meets the criteria for biocompatibility according to these standards.

Sterilization Validation:

The updated steam sterilization parameters were validated according to ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 demonstrating a sterility assurance level (SAL) of 10-9.

Shelf Life Testing:

The shelf life of the subject Simplant® Digital Guide is 2 weeks. To ensure the performance of subject Simplant® Digital through the claimed shelf life, all the performed bench testing on subject device was executed on samples that were sterilized and subjected to real-time aging for 2 weeks.

The results from the non-clinical performance testing, in combination with an updated design process, support substantial equivalence of the subject device Simplant® Digital Guide to the predicate device Simplant® Guide (K170849).

Clinical Performance Data.

No data from human clinical studies has been included to support the substantial equivalence of the Simplant® Digital Guide.

Conclusion Regarding Substantial Equivalence

The subject Simplant® Digital Guide is a patient specific surgical template which is intended for use in assisting placement of dental implants. The Simplant® Digital Guide has identical Indications for Use, exhibits identical fundamental design features and similar principles of operation as the predicate Simplant® Guide cleared under premarket notification K170849. Test data to verify the performance of the Simplant® Digital Guide has been included. The results of this testing, and the comparison with the predicate device, support substantial equivalence.

Regulation Number and Section

§ 872.3980 Endosseous dental implant accessories.

(a)
Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.