(130 days)
No
The device description and performance studies focus on the material properties and fabrication process of a ceramic blank for dental restorations. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a partially sintered ceramic blank used to fabricate dental restorations; it does not directly provide therapy.
No
Explanation: The device description clearly states that Cercon® is a partially sintered ceramic blank used to fabricate dental restorations (crowns and bridges). Its intended use is for actual treatment (restoration), not for diagnosing conditions or diseases.
No
The device description clearly states that Cercon® is a partially sintered ceramic blank composed of yttria stabilized zirconium oxide, which is a physical material used to fabricate dental restorations. It is not software.
Based on the provided information, the device Cercon® is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for fabricating dental restorations (crowns and bridges) for anterior and posterior locations. This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a ceramic blank used to create dental prosthetics. It is processed and then placed in the patient's mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and fit of the finished restoration, which are relevant to a dental prosthetic, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Cercon® does not fit this description.
N/A
Intended Use / Indications for Use
Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The subject device, Cercon® is a partially sintered ceramic blank composed of yttria stabilized zirconium oxide, (yttria stabilized tetragonal zirconia particle, Y-TZP). The subject device. Cercon® is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate all ceramic restorations. Cercon® blanks are zirconia based millable blanks (yttria-) stabilized zirconium oxide (zirconia) (Y-TZP)) that are used for all ceramic restorations for anterior and posterior locations. Specifically, Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
The subject device, Cercon® is available in various shades (colors) for esthetics. Specifically, the subject Cercon® material is offered in the following shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and white.
The sintered restorations which are fabricated using the subject Cercon® material may be veneered with compatible veneering porcelains.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior locations (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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)
Study Type: Non-Clinical Performance Data (Physical properties and Biocompatibility testing)
Physical properties:
- In accordance with ISO 6872:2015 (Dentistry - Ceramic materials), the product must meet the requirements for the appropriate type and class for its clinical usage. Both the proposed device, Cercon®, and the predicate device, BruxZir™ Anterior (K143330), meet the requirements of the applicable type and class for its clinical usage (Table 5.3).
- In addition to ISO testing, verification testing on finished restorations fabricated with the Cercon material was conducted. All restorations were milled and sintered in accordance with the directions instructions for use and visual inspection for cracks was performed. All finished dental restorations were found to be crack-free.
- Comparative evaluation of finished restorations fabricated using the subject Cercon® material and the predicate Cercon ht (K112152) material was also conducted. The restorations were evaluated for fit, margin, surface quality, and overall impression of dental objects (dental restorations). Results of the evaluation met the predetermined acceptance criteria.
Key Results: The performance of the proposed device, Cercon® satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Biocompatibility Testing:
- Cytotoxicity testing according to ISO 10993-5 (Biological evaluation of medical devices) was completed to characterize the biocompatibility of the proposed device Cercon®.
- Previously cleared devices (Cercon® Base, K051462 and Cercon® ht, K112152) were utilized to support biocompatibility for the proposed device Cercon®.
Key Results: Results of the testing support the biocompatibility of proposed device, Cercon®.
Clinical Performance Data: Not applicable. No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Cercon®.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Dentsply Sirona Mr. Karl Nittinger Senior Manager, Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404
Re: K162888
Trade/Device Name: Cercon Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 25, 2017 Received: January 26, 2017
Dear Mr. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runna, DDS, MA
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162888
Device Name Cercon®
Indications for Use (Describe)
Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
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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3
Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404
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SECTION 5. 510(k) SUMMARY
for
Cercon® (K162888)
-
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: February 22, 2017
2. Device Name:
| • Proprietary Name: | Cercon® |
|---|---|
| • Common Name: | zirconia based millable blank |
| • Classification Name: | Porcelain powder for clinical use |
| • CFR Number: | 21 C.F.R. 872.6660 |
| • Device Class: | II |
| • Product Code: | EIH |
1. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| BruxZir™ Anterior | K143330 | Prismatik Dentalcraft, |
| Inc |
| Reference Device for
| Biocompatibility and composition | 510(k) | Company Name |
|---|---|---|
| Cercon® Base | K051462 | DeguDent GmbH |
| Cercon® ht | K112152 | DeguDent GmbH |
| Reference Device for specific
| indications for use statement | 510(k) | Company Name |
|---|---|---|
| CELTRA Press | K161269 | DeguDent GmbH |
4
4. Description of Device:
The subject device, Cercon® is a partially sintered ceramic blank composed of yttria stabilized zirconium oxide, (yttria stabilized tetragonal zirconia particle, Y-TZP). The subject device. Cercon® is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate all ceramic restorations. Cercon® blanks are zirconia based millable blanks (yttria-) stabilized zirconium oxide (zirconia) (Y-TZP)) that are used for all ceramic restorations for anterior and posterior locations. Specifically, Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
The subject device, Cercon® is available in various shades (colors) for esthetics. Specifically, the subject Cercon® material is offered in the following shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and white.
The sintered restorations which are fabricated using the subject Cercon® material may be veneered with compatible veneering porcelains.
-
- Indications for Use:
Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
- Indications for Use:
-
- Substantial Equivalence:
The proposed Cercon® has similar indications for use as the predicate BruxZir™ Anterior, K143330. The indications are specifically defined as crowns and 3-unit bridges in anterior and posterior regions. The proposed Cercon® meets the requirement of flexural strength for this indication in accordance with ISO 6872:2015 (Dentistry -Ceramic materials) Type II Class 4 material. See Technological Characteristics for more details.
- Substantial Equivalence:
5
| Proposed Device | Primary Predicate Device | Secondary Predicate Device | Differences |
|---|---|---|---|
| Cercon® | |||
| K162888 | BruxZir™ | ||
| Anterior | |||
| K143330 | CELTRA Press | ||
| K161269 | |||
| Indications for Use: | |||
| Cercon® is indicated | |||
| for all ceramic | |||
| restorations for | |||
| anterior and posterior | |||
| locations, including | |||
| crowns and 3-unit | |||
| bridges in anterior and | |||
| posterior regions. | Indications for Use: | ||
| The device is | |||
| indicated for use by | |||
| dental technicians in | |||
| the construction of | |||
| custom made all | |||
| ceramic restorations | |||
| for anterior and | |||
| posterior location. | Indications for Use: | ||
| CELTRA Press is an all- | |||
| ceramic system for the | |||
| creation of | |||
| Occlusal veneers | |||
| Thin veneers | |||
| Veneers | |||
| Inlays | |||
| Onlays | |||
| Crowns in the anterior and | |||
| posterior region | |||
| 3-unit bridges in the anterior | |||
| and posterior region | |||
| 3-unit bridges in the | |||
| premolar region up to the | |||
| second premolar as the | |||
| terminal abutment | |||
| Crown, splinted crown or 3 | |||
| unit bridge up to the second | |||
| premolar placed on top of | |||
| an implant abutment | The Indications | ||
| for Use for the | |||
| proposed device, | |||
| Cercon® includes | |||
| additional clarity | |||
| and are | |||
| specifically | |||
| defined as | |||
| intended for use | |||
| in the fabrication | |||
| of crowns and 3- | |||
| unit bridges in | |||
| anterior and | |||
| posterior regions. |
Table 5.1 Indications for Use Comparison
Composition comparison
The proposed device, Cercon® is primarily composed of Zirconium Oxide (ZrO2). Though the exact composition of the predicate BruxZir™ Anterior, K143330 is not available; the 510(k) Summary for the BruxZir™ Anterior 510(k) K143330 describes the predicate as zirconia milling blanks which are the same as the proposed device, Cercon®.
The proposed device, Cercon® consists of the same base (primary) composition as previously cleared devices, Cercon® Base (K051462) and Cercon® ht (K112152). Base composition for the proposed device Cercon® as well as reference devices Cercon® Base (K051462) and Cercon® ht (K112152) is Zirconium Oxide (ZrO2).
Technological Characteristics:
The proposed device, Cercon® was classified and tested in accordance with ISO 6872:2015 (Dentistry - Ceramic materials). Cercon® classification and clinical usage is noted below:
Type II: All other forms of ceramic products
Class 4:
Class 4a: Monolithic ceramic for three-unit prostheses involving molar restoration Class 4b: Partially or fully covered substructure for three-unit prostheses involving molar restoration
6
| Physical
Properties
ISO 6872 | Proposed Device
Cercon®
K162888 | Predicate Device
BruxZir™ Anterior
K143330 | ISO 6872:2015
Type II Class 4 | Differences |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flexural strength | Meets requirements per ISO
6872:2015 | Meets requirements, per
ISO 6872:2008 | Meets requirements per
ISO 6872:2015 | The proposed device Cercon®
is a Type II class 4 device in |
| Chemical solubility | Meets requirements per ISO
6872:2015 | Not listed | Meets requirements per
ISO 6872:2015 | accordance with ISO
6872:2015 standard while the
primary predicate BruxZir™ |
| Coefficient of thermal
expansion, CTE | A4
$10.1×10^{-6} K^{-1}$ (25-500°C)
$10.2×10^{-6} K^{-1}$ (25-600°C)
C4
$10.0×10^{-6} K^{-1}$ (25-500°C)
$10.1×10^{-6} K^{-1}$ (25-600°C) | $11 x 10^{-6}$ / K
(100-500°C) | $9.80±0.06 x 10^{-6} K^{-1}$
(25°C-500°C) | Anterior, K143330 is a Type
II class 6 (per 510(k)
summary) in accordance with
ISO 6872:2008 standard.
Both the proposed device
Cercon® and the predicate |
| Radioactivity | Meets requirements per ISO
6872:2015 | Not listed | Meets requirements per
ISO 6872:2015 | device, BruxZir™ Anterior
(K143330) meet the
requirements for the |
| Uniformity | Meets requirements per ISO
6872:2015 | Not listed | Not listed | appropriate type and class for
its clinical usage. The |
| Mixing and
Condensation
Properties of type I
ceramics | Not applicable | Not listed | Not listed | secondary predicate, CELTRA
Press (K161269) is a type II
class 4 material per ISO
6872:2015 and meets the |
| Shrinkage factor | Meets requirements per ISO
6872:2015 | Not listed | Not listed | requirements for its
indications for use same as the |
| Glass transition
temperature | Not applicable | Not listed | Not listed | proposed device, Cercon®. |
| Freedom from
extraneous materials | Meets requirements per ISO
6872:2015 | Not listed | Not listed | |
| Fracture Toughness | Meets requirements per ISO
6872:2015 | Not listed | Not listed | |
Table 5.3 Physical Properties per ISO 6872 standard
7
Both the proposed device Cercon® and the predicate device, BruxZir™ Anterior (K143330) meet the requirements for the appropriate type and class for its clinical usage. The secondary predicate, CELTRA Press (K161269) is a type II class 4 material per ISO 6872:2015 and meets the requirements for its indications for use same as the proposed device. Cercon®. The strength of the proposed Cercon® meets the requirement for ISO 6872:2015 for the defined indications for use.
7. Non-Clinical Performance Data:
Physical properties
In accordance with ISO 6872:2015 (Dentistry - Ceramic materials), the product must meet the requirements for the appropriate type and class for its clinical usage. Both the proposed device, Cercon®, and the predicate device, BruxZir™ Anterior (K143330), meet the requirements of the applicable type and class for its clinical usage (Table 5.3).
In addition to ISO testing, verification testing on finished restorations fabricated with the Cercon material was conducted.. All restorations were milled and sintered in accordance with the directions instructions for use and visual inspection for cracks was performed. All finished dental restorations were found to be crack-free.
Comparative evaluation of finished restorations fabricated using the subject Cercon® material and the predicate Cercon ht (K112152) material was also conducted. The restorations were evaluated for fit, margin, surface quality, and overall impression of dental objects (dental restorations). Results of the evaluation met the predetermined acceptance criteria.
The performance of the proposed device, Cercon® satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Biocompatibility Testing
Cytotoxicity testing according to ISO 10993-5 (Biological evaluation of medical devices) was completed to characterize the biocompatibility of the proposed device Cercon®. In addition, previously cleared devices (Cercon® Base, K051462 and Cercon® ht, K112152) were utilized to support biocompatibility for the proposed device Cercon®. Results of the testing support the biocompatibility of proposed device, Cercon®.
8. Clinical Performance Data:
Not applicable. No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Cercon®.
8
9. Conclusion Regarding Substantial Equivalence:
The comparative information included in this section regarding the proposed device, Cercon®, supports substantial equivalence to the predicate device, BruxZir™ Anterior cleared under premarket notification K143330 . Substantial equivalence of the subject Cercon device is supported by the following determinative factors:
- It has the same intended use and incorporates the same fundamental technology as the . primary predicate device (BruxZir™ Anterior, K143330).
- . It has the same specific indications for use as secondary predicate device (CELTRA Press, K161269).
- It has the same base (primary) composition Zirconium Oxide (ZrO2) as the reference . devices Cercon® Base (K051462) and Cercon® ht (K112152).
- . It has similar technological characteristics as the predicate. The proposed device, Cercon® as well the predicate device, BruxZir™ Anterior, K143330 meet the requirement of the related type and class for its usage.