CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

Device Description

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090.

The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi".

The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm.

The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

AI/ML Overview

The provided FDA 510(k) premarket notification for "CEREC Guides" focuses on demonstrating substantial equivalence to a predicate device ("SIMPLANT Guide," K170849) through non-clinical performance data. It does not involve a multi-reader multi-case (MRMC) study or artificial intelligence (AI) performance evaluation. Therefore, many of the requested elements for an AI-based device, such as ground truth establishment by experts, adjudication methods, and MRMC study details, are not applicable here.

Here's a breakdown of the available information relevant to acceptance criteria and study proving device performance:

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

The document does not present a formal table of acceptance criteria with specific numerical thresholds and corresponding performance results in the format requested, typical for AI/ML device submissions. Instead, it describes various non-clinical tests conducted to support substantial equivalence. The "acceptance criteria" are implied by the successful completion of these validation tests.

Acceptance Criterion (Implied)	Reported Device Performance and Study Type
Software Validation: Conformity with IEC 62304 and FDA guidance for software in medical devices.	Validation Study: Tested to ensure conformity with IEC 62304 ("Medical device software - Software lifecycle processes") and FDA guidance "Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May, 2005)." This included validation of input data from Galileos Implant and calibration of the compatible milling unit. (Implied: Software functions correctly and safely).
Accuracy of Milled Guides: Deviation of apical drill position.	Validation Testing: Confirmed the accuracy of the milled CEREC Guide devices by comparing the surgical guide design in CEREC SW to the apical position determined from the implant treatment plan developed using Galileos Implant dental implant planning software. (Implied: Milled guides accurately reflect the treatment plan).
Material Strength: Mechanical properties of the PMMA material.	Material Strength Analysis: Based on requirements of ISO 10477 ("Dentistry - Polymer-based crown and bridge veneering materials"), published clinical literature on intra-oral surgical drilling and bite forces, and the PMMA material characteristics of CEREC Guides and PMMA reference devices. (Implied: Material is strong enough for intended use).
Drill Sleeve Retention: Force required to push out bonded drill sleeves.	Bench Test Data: Supported the requirement that the force needed to push out the bonded CEREC Guide 3 drill sleeve exceeds intra-surgical drilling forces reported in published literature. (Implied: Drill sleeves remain secure during use).
Biocompatibility: Safety of materials in contact with the patient.	Biocompatibility Testing: Conducted on the CEREC Guide Bloc PMMA material and the finished CEREC Guide 3 (incorporating PMMA, Guide Sleeves, and Calibra® Universal adhesive). This was done with reference to the June 2016 CDRH Guidance on ISO 10993-1. (Implied: Materials are biocompatible).
High-Level Disinfection Process Validation: Effectiveness of disinfection.	Validation Testing: Validated the high-level disinfection process recommended for single-use CEREC Guides prior to use, referencing the March 2015 CDRH/CBER Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." (Implied: Disinfection method is effective).

2. Sample size used for the test set and the data provenance

The document describes non-clinical bench and validation tests rather than a test set of patient data. Specific sample sizes for these engineering and material tests (e.g., number of guides milled for accuracy, number of drill sleeves tested for retention) are not detailed in this summary. The data provenance is from the manufacturer's internal testing as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on non-clinical engineering and performance testing, not on interpretative performance (like image reading) where expert ground truth is typically established. The "ground truth" for the device's function is its design specifications and physical properties, tested through controlled experiments.

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

Not applicable. There's no human adjudication process described, as it's not a study evaluating human interpretation or AI output against a consensus.

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

No MRMC study was done. This device, CEREC Guides, is a physical, milled surgical guide, not an AI or software-assisted diagnostic tool that would typically undergo an MRMC study to assess reader performance. The submission explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides."

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

Not applicable. This is not an AI algorithm. Its performance is evaluated based on its physical properties, manufacturing accuracy, and integration with existing approved software and hardware. The "device" itself is the physical CEREC Guide.

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

The "ground truth" for the performance tests is based on:

Design Specifications and Reference Standards: The intended design dimensions and functionalities derived from the Galileos Implant treatment planning software served as the reference for accuracy testing.
Established Material Properties and Biocompatibility Standards: ISO standards (e.g., ISO 10477, ISO 10993-1) and published literature for material strength and biocompatibility served as the benchmark.
Validated Disinfection Protocols: FDA and industry guidelines for high-level disinfection processes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment for a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2019

Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401

Re: K190059

Trade/Device Name: CEREC Guides Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: Class I Product Code: NDP Dated: June 28, 2019 Received: July 1, 2019

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.

{1}------------------------------------------------

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 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. Acting Division Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMANSERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190059

Device Name

CEREC Guides

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract symbol on the left, resembling a curved or flowing shape. To the right of the symbol are the words "Dentsply" on the top line and "Sirona" on the bottom line, with both words in a simple, sans-serif font. The color of the logo is a muted gray.

K190059: 510(k) SUMMARY CEREC Guides

1. Submitter Information:

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

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: 27-September-2019

2. Device Name:

Proprietary Name: CEREC Guides ● ● Classification Name: Endosseous dental implant accessories. 21 CFR 872.3980 . CFR Number:
Class I . Device Class:
. Product Code: NDP (Accessories, Implant Dental, Endosseous)

Predicate and ReferenceDevices: 3.

The predicate device that has been identified relating to the substantial equivalence of the CEREC Guides is:

Predicate Device	510(k)Clearance	Company Name
SIMPLANT Guide	K170849	Dentsply Sirona

{4}------------------------------------------------

Reference Devices:

Reference Device	510(k) Clearance	Manufacturer
Sirona Dental CAD/CAM System	K181520	Dentsply Sirona
Galileos Implant (dental implant planningsoftware)	K093090	SICAT GmbH & Co. KG
Calibra Universal Self-Adhesive ResinCement	K073173	Dentsply Sirona
Weiland Zeno CAO Temporary PMMADisc	K071548	Merz Dental GmbH

4. Description of Device:

{5}------------------------------------------------

રું Indications for Use:

6. Substantial Equivalence:

The CEREC Guide has the same intended use and incorporate the same fundamental technology as the predicate SIMPLANT Guide cleared under premarket notification K170849. The indications for use of the subject CEREC Guides in comparison to the indications for use of the predicate SIMPLANT Guide (K170849) references the CEREC Guide design and fabrication functionality using the Sirona Dental CAD/CAM System's (K181520) CEREC Chairside software and CAM equipment as well as the other system components.

Summary comparison of the intended use, indications for use, and features of the subject CEREC Guides with those of the predicate SIMPLANT Guide cleared under K170849 is presented in Tables 6.1 and 6.2.

Table 6.1: Indications for Use

Subject Device	Predicate Device
CEREC Guides	SIMPLANT Guide(K170849)
Indications for Use
CEREC Guides are intended to support the dentist ororal surgeon when drilling for placement of dentalimplants. CEREC Guides are intended to be designedand fabricated using the Sirona Dental CAD/CAMSystem's CEREC Chairside software and CAMequipment, Galileos Implant dental implant planningsoftware, and Calibra Universal Self-Adhesive ResinCement.	The SIMPLANT Guide is intended for use inassisting placement of dental implants.
Subject DeviceCEREC Guides	Predicate DeviceSIMPLANT Guide(K170849)	SimilaritiesAndDifferences
Technology
Chairside CAD/CAM design and milling.	Internal design and fabrication bystereolithography.	The subject CEREC Guides are designedand fabricated by the clinician usingCAD/CAM design and milling atchairside while the predicate device(K170849) is designed in consultationwith the clinician and fabricated bystereolithography methods in an internalmanufacturing environment.The technological differences aremitigated by bench testing included insupport of substantial equivalence.
Material
- Poly(methyl methacrylate) acrylicmillable block.- Calibra Universal Self-Adhesive ResinCement.- Integral titanium drill guide sleeves.	- Acrylic epoxy resin.- Medical grade adhesive.- Titanium or stainless steel drillguide sleeves.	The subject CEREC Guides are fabricatedby milling from solid poly(methylmethacrylate) acrylic blocks while thepredicated device (K170849) aremanufactured by stereolithography andcomposed of acrylic epoxy resin.The particular material formulationdifferences between the subject device andthe predicate device (K170849) aremitigated by biocompatibility testingincluded in support of substantialequivalence.
Subject DeviceCEREC Guides	Predicate DeviceSIMPLANT Guide(K170849)	SimilaritiesAndDifferences
Design and Features
- Patient-specific dental implantplacement template.- Minimal wall thickness: 1 mm- Integral metallic (titanium) guidesleeves with position and dimensionsbased on the clinician's pre-operativedental implant treatment plan.	- Patient-specific dental implantplacement template.- Minimal wall thickness: 2.5 mm- Integral metallic (titanium orstainless steel) guide sleeves withposition and dimensions based onthe clinician's pre-operativedental implant treatment plan.	The design features of the subject CERECGuides are similar to those of thepredicate device (K170849). Both arepatent-specific devices whose design isfinalized according to the clinician's pre-operative treatment plan.The specific design differences betweenthe subject device and the predicate device(K170849) are mitigated by bench testingincluded in support of substantialequivalence.
Sterilization / Disinfection Method
- Fabricated by the clinician and are non-sterile when completed.- Single-use devices processed via high-level disinfection by the end userclinician prior to initial use.	- Delivered non-sterile to theclinician.- Single-use devices processed viasteam sterilization by the enduser clinician prior to initial use.	The subject and predicate (K170849)devices are either “finalized” (fabricatedby the clinician at chairside in the case ofthe subject device or delivered from themanufacturer to the clinician in the case ofthe predicate device) in a non-sterile stateand must be processed by the end userprior to clinical use.The differences in the specific method forpre-operative processing of the subjectand predicate (K170849) devices aremitigated by validation testing included insupport of substantial equivalence.

The indications for use of the CEREC Guides as subject to this premarket notification include identification of the reference devices which are utilized in the chairside design and fabrication of the subject devices and are listed in support of substantial equivalence. The intended use of the reference devices [Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520), Galileos Implant dental implant treatment planning software (K093090), and Calibra Universal Self-Adhesive Resin Cement (K073173)] include the design and fabrication of dental prosthetic restorations and CAD/CAM dental abutments, the planning of oral surgery, and restorative dental procedures, respectively. The specific differences related to the intended use of the subject device as compared to the reference devices was mitigated by bench testing.

{6}------------------------------------------------

Table 6.2: Design

{7}------------------------------------------------

Table 6.2: Design (continued)

{8}------------------------------------------------

7. Non-Clinical Performance Data

Testing to verify the performance requirements of the subject CEREC Guides was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.

Tests included in this premarket notification:

. Validation of the device's software, including input data from Galileos Implant and calibration of the compatible milling unit, in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and with deliverables compiled and included with reference to Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May, 2005).
. Validation testing conducted to confirm the accuracy of the milled CEREC Guide devices comparing the CEREC SW surgical guide design with respect to deviation of the apical position of the drill with the apical position determined from the implant treatment plan developed using the Galileos Implant dental implant planning software.
Material strength analysis based on the requirements of ISO 10477 (Dentistry -. Polymer-based crown and bridge veneering materials), published clinical literature referencing forces applied during intra-oral surgical drilling and bite forces, and the PMMA material characteristics of the subject CEREC Guides and the PMMA reference devices.
Bench test data supporting the requirement that the force required to push out the . bonded CEREC Guide 3 drill sleeve exceeds the intra-surgical drilling forces that have been reported in published literature.
· Biocompatibility testing on the CEREC Guide Bloc PMMA material and on the finished CEREC Guide 3 (incorporating the CEREC Guide Bloc PMMA material, the Guide Sleeves, and the Calibra® Universal adhesive). Biocompatibility evaluation and testing were conducted with reference to the June, 2016, CDRH Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
· Validation of the high-level disinfection process which is recommended for the singleuse CEREC Guides prior to their use was conducted with reference to the March, 2015 CDRH/CBER Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

{9}------------------------------------------------

Clinical Performance Data 8.

No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides.

Conclusion Regarding Substantial Equivalence 9.

The information included in this premarket notification supports the substantial equivalence of the subject CEREC Guides. The subject CEREC Guides have the same intended use as the legally marketed predicate device cleared under premarket notification K170849. The subject device also has similar indications for use and incorporates the same fundamental technology as the predicate device (K170849).

Performance data, software integration deliverables, and analyses are included in this premarket notification to verify the design, functionality, and safety requirements of CEREC Guides. The results of the testing included in this premarket notification support a determination of 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.