(28 days)
No
The summary describes a standard CBCT device and its image reconstruction process, which is based on mathematical calculations, not AI/ML. The reason for the submission is a change in the bite block material and an update to the image management software (referenced in a separate K number), neither of which indicate AI/ML functionality. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
The device is described as a diagnostic imaging system (computed tomography x-ray unit) used to generate images for dental treatment, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to generate 3D, panoramic and cephalometric ... X-ray images in dental radiography" and provides "diagnostic details of the maxillofacial areas for a dental treatment."
No
The device description clearly states it is a cone beam CT x-ray device, which is a hardware system for image acquisition. The submission also mentions a new bite block component, further indicating it is a physical device. While it includes image management software, the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "x-ray unit intended to generate 3D, panoramic and cephalometric... X-ray images in dental radiography." It is used to "provide diagnostic details of the maxillofacial areas for a dental treatment." This describes an imaging device used for anatomical visualization, not for testing biological samples (like blood, urine, or tissue) to diagnose disease or other conditions.
- Device Description: The description details the mechanics of an X-ray imaging system (X-ray tube, sensor, rotation, image reconstruction). This aligns with an imaging device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any components or processes related to the analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.
The premarket notification is related to the biological evaluation of materials in contact with the patient (the bite block), which is a requirement for many medical devices, not specifically IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
OAS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
maxillofacial areas
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
physicians, dentists, and x-ray technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data and Performance Testing (New Bite Foam) Cytotoxicity, L 929-Proliferation, EN ISO 10993-1, -5, -12. Result: Not cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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
1
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
2
Indications for Use
510(k) Number (if known) K232487
Device Name ProVecta 3D Prime and ProVecta 3D Prime Ceph
Indications for Use (Describe)
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.
| 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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3
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 SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Phone: + 49 (0) 7142 70 5-0
Fax: + 49 (0) 7142 705-500
E-Mail: info@duerr.de
www.duerrdental.com | Establishment Registration
Name in FURLS:
Duerr DENTAL SE |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange
Director of Quality Management
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen, Germany
Phone: + 49 (0) 7142 70 5-190
Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski
Director of Quality and Regulatory
Air Techniques, Inc.
1295 Walt Whitman Road
Melville, NY 11747, USA
U.S. Phone: 516-214-5574
E-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 |
4
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 |
-
- 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:
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
5
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 Ceph
K193139 | ProVecta 3D Prime | ProVecta 3D Prime Ceph | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indications for Use | ProVecta 3D Prime Ceph is a
computed tomography x-ray
unit intended to generate 3D,
panoramic and cephalometric
X-ray images in dental
radiography for adult and
pediatric patients. It provides
diagnostic details of the
maxillofacial areas for a dental
treatment. The device is
operated and used by
physicians, dentists, and x-ray
technicians. Not intended for
mammography use. | ProVecta 3D Prime and ProVecta 3D Prime Ceph are computed
tomography x-ray units intended to generate 3D, panoramic anc
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. | ProVecta 3D Prime and ProVecta 3D Prime Ceph are computed
tomography x-ray units intended to generate 3D, panoramic anc
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. | |
| Image Acquisition Modes | Panoramic, cephalometric,
and computed tomography | SAME except without
cephalometric | 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 and
3D, 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 and
headrest | SAME | SAME | |
| Mechanical | Compact design | SAME | SAME | |
| Descriptive Information | | ProVecta 3D Prime Ceph
K193139 | ProVecta 3D Prime | ProVecta 3D Prime Ceph |
| Electrical | | LDCP logic circuit (Low
Dark Current
Processing) | SAME | SAME |
| Software | | VistaSoft, DICOM 3.0
compatible | SAME | SAME |
| 2D Image Viewing
Program | | VisionX | SAME | SAME |
| 3D Image Viewing
Program | | VisionX | SAME | SAME |
| Anatomical Sites | | Maxillofacial | SAME | SAME |
| Image
Receptor | Computed
Tomography | Xmaru1404CF | SAME | SAME |
| | Panoramic | Xmaru1404CF | SAME | SAME |
| | Cephalometric | Xmaru 2602CF | N/A | SAME |
| Size of Imaging
Volume (cm) | | Xmaru1404CF: Max.
10x8.5 | SAME | SAME |
| Pixel
Resolution | Computed
Tomography | 2.5 lp/mm - 4x4 binning
Does not support:
5.0 lp/mm - 2x2 binning | SAME | SAME |
| | Panoramic | 2.5 lp/mm - 4x4 binning
Does not support:
5.0 lp/mm - 2x2 binning | SAME | SAME |
| | Cephalometric | Xmaru 2602CF | N/A | SAME |
| Pixel Size
Computed | Computed
Tomography | Xmaru1404CF :
99 µm - 2x2 binning
198 µm- 4x4 binning | SAME | SAME |
| | Panoramic | Xmaru1404CF :
99 µm - 2x2 binning
198 µm- 4x4 binning | SAME | SAME |
| | Cephalometric | Xmaru 2602CF
200 x 200 µm | N/A | SAME as Predicate |
| Descriptive Information | ProVecta 3D Prime Ceph
K193139 | ProVecta 3D Prime | ProVecta 3D Prime Ceph | |
| Photograph | Image: ProVecta 3D Prime Ceph K193139 | Image: ProVecta 3D Prime
Without CEPH Arm. | Image: ProVecta 3D Prime Ceph
Identical appearance, no
change. | |
6
7
-
- 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.
-
- 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
-
- Clinical Data Clinical data is not required for a finding of substantial equivalence.
-
- 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.