Pro Vecta 3D Prime and ProVecta 3D Prime Ceph are computed tomography x-ray units intended to generate 3D, panoramic and cephalometric (ProVecta 3D Prime Ceph Model) X-ray images in dental radiography for adult and pediatric patients. They provide diagnostic details of the maxillofacial areas for a dental treatment. The devices are operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

Device Description

This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The X-rays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard. The ProVecta 3D Prime model does not have the CEPH function.

This premarket notification is because of the biological evaluation of medical devices documentation according to EN ISO 10993-1:2020. The revision of the document is the inclusion of the Comfort Bite Foam for the bite block with direct patient contact. The relevant documents regarding biological safety were included and evaluated in this biological evaluation. Furthermore, the Biological Evaluation has been updated to the latest Version of the standard. The name, application and biocompatibility-relevant materials of the product have not changed since the last version. In addition to the current bite block (REF: 2210200100), two new, more comfortable variants were developed:

standard bite block: an optimized version of the existing bite block
comfort bite block: an extension of the existing bite block

The image management software was recently updated in K213326.

AI/ML Overview

This document describes a 510(k) premarket notification for the "ProVecta 3D Prime and ProVecta 3D Prime Ceph" devices. The submission primarily addresses a change in the bite-block material and an updated biological evaluation, not a new or significantly altered imaging algorithm. Therefore, the information requested for acceptance criteria and a study proving device performance (especially related to AI or standalone algorithm performance) is not fully present in the provided text.

Based on the provided text, here's a breakdown of the available information:

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

The document focuses on demonstrating substantial equivalence to a predicate device (ProVecta 3D Prime Ceph, K193139) because of a change in bite-block material and an updated biological evaluation. There are no explicit "acceptance criteria" for imaging performance described in the text, nor are there reported device performance metrics in terms of clinical accuracy or diagnostic efficacy for the imaging capability itself.

The only "performance testing" mentioned relates to the new bite foam:

Acceptance Criteria (for New Bite Foam)	Reported Device Performance (for New Bite Foam)
Not cytotoxic (based on ISO 10993 standards)	Result: Not cytotoxic.

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

For the new bite foam testing, specific sample sizes for cytotoxicity testing are not provided in the text. There's no information on a "test set" for imaging performance, as the submission does not involve an evaluation of a new imaging algorithm.

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

Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation.

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 submission is for an X-ray unit, not an AI-assisted diagnostic device. The imaging software (VisionX 3.0) is referenced as an updated component, but the submission itself is not about the performance of the software.

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

No standalone algorithm performance study was done. This submission is for an X-ray unit, not a standalone algorithm.

7. The type of ground truth used

For the biological evaluation, the ground truth was established by laboratory testing for cytotoxicity based on EN ISO 10993-1, -5, -12 standards. No clinical ground truth (pathology, outcomes data, or expert consensus) for diagnostic accuracy is mentioned as this is not the focus of this 510(k).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this submission is not about an AI algorithm.

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

Not applicable. There is no mention of a training set.

Summary

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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 14, 2023

Durr Dental SE % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K232487

Trade/Device Name: Provecta 3D Prime and Provecta 3D Prime Ceph Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: August 10, 2023 Received: August 17, 2023

Dear Daniel Kamm:

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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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) K232487

Device Name ProVecta 3D Prime and ProVecta 3D Prime Ceph

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)

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510(k) Summary, DÜRR DENTAL SE,

ProVecta 3D Prime and ProVecta 3D Prime Ceph, K232487

This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92. Date Summary Prepared: September 14, 2023

Submitter's Identification: (Below) 1.

Submitter's Identification:	DÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-BissingenGermanyPhone: + 49 (0) 7142 70 5-0Fax: + 49 (0) 7142 705-500E-Mail: info@duerr.de www.duerrdental.com	Establishment RegistrationName in FURLS:Duerr DENTAL SE
Establishment Registration Number:	3015509619
Submitter's Contact:	Mr. Oliver LangeDirector of Quality ManagementDÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-Bissingen, GermanyPhone: + 49 (0) 7142 70 5-190Email: oliver.lange@duerrdental.com
U.S. Agent & Contact:	Mr. Joseph LatkowskiDirector of Quality and RegulatoryAir Techniques, Inc.1295 Walt Whitman RoadMelville, NY 11747, USAU.S. Phone: 516-214-5574E-Mail: Joseph.Latkowski@airtechniques.com

2. Device:

Trade /Proprietary Name:	ProVecta 3D Prime and ProVecta 3D Prime Ceph
Device:	X-Ray, Tomography, Computed, Dental
Regulation Description:	Computed tomography x-ray system
Regulation Medical Specialty:	Radiology
Review Panel:	Radiology
Product Code:	OAS
Regulation Number:	892.1750
Device Class:	2

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3. Predicate Device:

510(k) Number:	K193139
Manufacturer:	DÜRR DENTAL SE
Trade /Proprietary Name:	ProVecta 3D Prime Ceph
Device:	X-Ray, Tomography, Computed, Dental
Regulation Description:	Computed tomography x-ray system
Regulation Medical Specialty:	Radiology
Review Panel:	Radiology
Product Code:	OAS
Regulation Number:	892.1750
Device Class:	2

1. Reference Device: (Software used with the proposed device)

510(k) Number:	K213326
Manufacturer:	DÜRR DENTAL SE
Trade /Proprietary Name:	VisionX 3.0
Device:	Imaging Software
Regulation Description:	Medical image management and processing system
Regulation Medical Specialty:	Radiology
Review Panel:	Radiology
Product Code:	LLZ
Regulation Number:	892.2050
Device Class:	2

5. Device Description:

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since the last version. In addition to the current bite block (REF: 2210200100), two new, more comfortable variants were developed:

standard bite block: an optimized version of the existing bite block
comfort bite block: an extension of the existing bite block

The image management software was recently updated in K213326.

6. Indications for use:

ProVecta 3D Prime and ProVecta 3D Prime Ceph are computed tomography x-ray units intended to generate 3D, panoramic and cephalometric (ProVecta 3D Prime Ceph Model) X-ray images in dental radiography for adult and pediatric patients. They provide diagnostic details of the maxillofacial areas for a dental treatment. The devices are operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

7. Summary of the technological characteristics of the device compared to the predicate device:

Descriptive Information	ProVecta 3D Prime CephK193139	ProVecta 3D Prime	ProVecta 3D Prime Ceph
Indications for Use	ProVecta 3D Prime Ceph is acomputed tomography x-rayunit intended to generate 3D,panoramic and cephalometricX-ray images in dentalradiography for adult andpediatric patients. It providesdiagnostic details of themaxillofacial areas for a dentaltreatment. The device isoperated and used byphysicians, dentists, and x-raytechnicians. Not intended formammography use.	ProVecta 3D Prime and ProVecta 3D Prime Ceph are computedtomography x-ray units intended to generate 3D, panoramic anccephalometric (ProVecta 3D Prime Ceph Model) X-ray images indental radiography for adult and pediatric patients. Theyprovide diagnostic details of the maxillofacial areas for a dentaltreatment. The devices are operated and used by physicians,dentists, and x-ray technicians. Not intended formammography use.	ProVecta 3D Prime and ProVecta 3D Prime Ceph are computedtomography x-ray units intended to generate 3D, panoramic anccephalometric (ProVecta 3D Prime Ceph Model) X-ray images indental radiography for adult and pediatric patients. Theyprovide diagnostic details of the maxillofacial areas for a dentaltreatment. The devices are operated and used by physicians,dentists, and x-ray technicians. Not intended formammography use.
Image Acquisition Modes	Panoramic, cephalometric,and computed tomography	SAME except withoutcephalometric	SAME as predicate
Imaging Software	VisionX 3, includes 2D and 3D.Cleared in K192743	VisionX 3.0, includes 2D and 3D,updated in K213326	VisionX 3.0, includes 2D and3D, updated in K213326
Input Voltage	AC 200-240V	SAME	SAME
Tube Voltage	60-99 kV	SAME	SAME
Tube Current	4~16mA	SAME	SAME
Focal Spot Size	0,5 mm	SAME	SAME
Exposure Time	Max. 20 s	SAME	SAME
Slice Width	0.1 mm min.	SAME	SAME
Total Filtration	2.5 mm Al	SAME	SAME
Chin Rest	Bite block, chin rest andheadrest	SAME	SAME
Mechanical	Compact design	SAME	SAME
Descriptive Information		ProVecta 3D Prime CephK193139	ProVecta 3D Prime	ProVecta 3D Prime Ceph
Electrical		LDCP logic circuit (LowDark CurrentProcessing)	SAME	SAME
Software		VistaSoft, DICOM 3.0compatible	SAME	SAME
2D Image ViewingProgram		VisionX	SAME	SAME
3D Image ViewingProgram		VisionX	SAME	SAME
Anatomical Sites		Maxillofacial	SAME	SAME
ImageReceptor	ComputedTomography	Xmaru1404CF	SAME	SAME
	Panoramic	Xmaru1404CF	SAME	SAME
	Cephalometric	Xmaru 2602CF	N/A	SAME
Size of ImagingVolume (cm)		Xmaru1404CF: Max.10x8.5	SAME	SAME
PixelResolution	ComputedTomography	2.5 lp/mm - 4x4 binningDoes not support:5.0 lp/mm - 2x2 binning	SAME	SAME
	Panoramic	2.5 lp/mm - 4x4 binningDoes not support:5.0 lp/mm - 2x2 binning	SAME	SAME
	Cephalometric	Xmaru 2602CF	N/A	SAME
Pixel SizeComputed	ComputedTomography	Xmaru1404CF :99 µm - 2x2 binning198 µm- 4x4 binning	SAME	SAME
	Panoramic	Xmaru1404CF :99 µm - 2x2 binning198 µm- 4x4 binning	SAME	SAME
	Cephalometric	Xmaru 2602CF200 x 200 µm	N/A	SAME as Predicate
Descriptive Information	ProVecta 3D Prime CephK193139	ProVecta 3D Prime	ProVecta 3D Prime Ceph
Photograph	Image: ProVecta 3D Prime Ceph K193139	Image: ProVecta 3D PrimeWithout CEPH Arm.	Image: ProVecta 3D Prime CephIdentical appearance, nochange.

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1. Discussion of Similarities and Differences: This premarket notification is specifically for a change in the bite-block material. Because of the change in material, biocompatibility issues had to be addressed.
1. Non-Clinical Data and Performance Testing (New Bite Foam) Cytotoxicity, L 929-Proliferation, EN ISO 10993-1, -5, -12. Result: Not cytotoxic.

The following new documents have been added to our technical file: Test Report Chemical Analysis Comfort Bite Foam Test Report Cytotoxicity Comfort Bite Foam Test Report Cytotoxicity Packaging Comfort Bite Foam Test Report Bite Block Manufacturer Report Cytotoxicity-Datasheet, O.C.-PE RG 45 KB-D-No 5607267 Safety Information

1. Clinical Data Clinical data is not required for a finding of substantial equivalence.
1. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, Dürr Dental SE concludes that the ProVecta 3D Prime Ceph is substantially equivalent to the predicate device as described herein. The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.