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K Number
K234018
Device Name
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
Manufacturer
Dentsply Sirona
Date Cleared
2024-05-07

(139 days)

Product Code
NHAPNP
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - CEREC Cercon 4D™ Abutment Block - TiBase - CAD/CAM system The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
Device Description
The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials. CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.
More Information

K221402

K111421, K162888, K200191, K193408, K181520, K100152, K210610, K221094, K053384, K013867, K120414, K083805, K143022, K071638, K093321, K042429, K020646, K071370, K022562, K151324, K093615, K090154, K121585, K061410, K061629, K014235, K191152, K083496

No
The summary describes a CAD/CAM system for fabricating dental abutments from zirconia blocks. While CAD/CAM systems involve software for design and manufacturing, there is no mention of AI or ML being used in the design process, material selection, or manufacturing parameters. The performance studies focus on material properties and fatigue testing, not on the performance of any AI/ML algorithm.

Yes.
The device is intended for use in partially or fully edentulous mandibles and maxillae, supporting cement-retained restorations that attach to dental implants, directly addressing a health condition by restoring dental function.

No

The device is a system for fabricating dental restorations (abutment blocks, TiBase, CAD/CAM system) to support single cement-retained restorations in edentulous areas. It is designed for restorative purposes, not for diagnosing a condition or disease.

No

The device description explicitly states the system comprises three parts: CEREC Cercon 4D™ Abutment Block, TiBase, and CAD/CAM system. The abutment block and TiBase are physical components, not software. While a CAD/CAM system (which includes software) is part of the system, the overall device is not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Function: The CEREC Cercon 4D™ Abutment System is a system used to fabricate dental abutments and crowns for use with dental implants. It is a material and a process for creating a physical dental restoration.
  • Lack of Biological Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. The system works with materials (zirconia blocks) and a CAD/CAM system to create a physical device.

Therefore, the device falls under the category of a dental prosthetic or restorative device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

  • CEREC Cercon 4D™ Abutment Block
  • TiBase
  • CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Implant Systems:

  • Dentsply Sirona: PrimeTaper EV, OmniTaper EV, AstraTech OsseoSpeed TX, Frialit / XiVE, AstraTech Implant EV, Ankylos
  • BioHorizons: Internal connection
  • Nobel Biocare: Replace Select, Nobel Active, NobelReplace Conical Connection, Brânemark, NobelSpeedy Groovy
  • Straumann: Tissue Level, Bone Level
  • Thommen Medical: Element, Contact
  • Osstem/Hiossen: Osstem TS, USA: Hiossen ET
  • Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent
  • MIS: C1 Conical Connection, V3 Conical Connection, SEVEN internal hex, M4 internal hex
  • Altatec Camlog

CAD/CAM Systems:

  • Sirona Dental CAD/CAM System

Product codes (comma separated list FDA assigned to the subject device)

NHA, PNP

Device Description

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to the TiBase (Titanium base) used with dental implant systems. The following patient-specific ranges for CAD/CAM fabrication of the subject abutments are:

  • Maximum angulation of 20°
  • Minimal wall thickness of 0.5 mm
  • Gingival height ranges from 0.3-2.0 mm
  • Minimum abutment post height (i.e. length above the gingival height) of ≥ 4 mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxillae

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)

Performance Testing:
The proposed device was tested and conforms to ISO 6872:2015 (Amd 1. 2018) Dentistry-Ceramic Materials and ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants.
Flexural Strength (3-point bending strength) test according to ISO 6872:2015 Amd 1. 2018. Acceptance Criteria: >1,100 MPa. Results: Pass.

Fatigue Testing after steam sterilization according to ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants.

  • MIS Narrow Platform conical connection C1-10330 with CN-TB015 TiBase: Pass
  • MIS Standard Platform conical connection C1-08375 with CS-TB030 TiBase: Pass
  • DS XiVE S Plus implant D3.4/L15 with DS TiBase FX 3.4 S: Pass
  • Camlog Screw-Line Implant nominal size 3.8mm length 13.mm with Camlog Titanium Base CAD/CAM: Pass

New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations. The testing conducted together with historical data on file for the reference device (K111421) was leveraged to support performance of Dentsply Sirona TiBase/Third Party Implant Systems, and Dentsply Sirona TiBase/Dentsply Sirona Implant Systems, and Third Party TiBase/Third Party Implant Systems combinations.

Cleaning, Disinfection, and Sterilization Testing:
Sterilization validation testing was conducted in accordance with ISO 17665-1 to achieve a Sterility Assurance Level (SAL) of 10-6 for steam sterilization parameters.

CAD/CAM Software Validation & Verification Testing:
Software validation was performed to show the maximum and minimum design parameters for the CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System within the compatible CAD/CAM software. The following parameters are locked into the CAD/CAM software libraries: Maximum angulation of 20°, Minimal wall thickness of 0.5 mm.

Biocompatibility Testing:
A biological risk assessment was conducted. Tests conducted met ISO 10993 requirements: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), Irritation (ISO 10993-23:2021).

Conclusion: The nonclinical testing data supports the conclusion that the proposed device performs as well as the predicate device (K221402).

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.

K221402

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.

K111421, K162888, K200191, K193408, K181520, K100152, K210610, K221094, K053384, K013867, K120414, K083805, K143022, K071638, K093321, K042429, K020646, K071370, K022562, K151324, K093615, K090154, K121585, K061410, K061629, K014235, K191152, K083496

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

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 7, 2024

Dentsply Sirona Rebecca Sporer Principal Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K234018

Trade/Device Name: CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: December 19, 2023 Received: April 5, 2024

Dear Rebecca Sporer:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

2

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-regulatory-

assistance/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.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K234018

Device Name

CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

Indications for Use (Describe)

CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

  • CEREC Cercon 4D™ Abutment Block
  • TiBase
  • CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Implant Systems:

• Dentsply Sirona: PrimeTaper EV, OmniTaper EV, AstraTech OsseoSpeed TX, Frialit / XiVE, AstraTech Implant EV, Ankylos

  • · BioHorizons: Internal connection
    · Nobel Biocare: Replace Select, Nobel Active, NobelReplace Conical Connection, Brânemark, NobelSpeedy Groovy

  • · Straumann: Tissue Level, Bone Level

  • · Thommen Medical: Element, Contact

  • · Osstem/Hiossen: Osstem TS, USA: Hiossen ET

  • · Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent

  • · MIS: C1 Conical Connection, V3 Conical Connection, SEVEN internal hex, M4 internal hex

  • · Altatec Camlog

CAD/CAM Systems: ·Sirona Dental CAD/CAM System

Manufacturer: Dentsply Sirona Implant Implant: Primetaper EV Platform: S; TiBase AT EV 3.6 GH 1 S; Reference: 6586312; Size: S Platform: M; TiBase AT EV 4.2 GH 1 L; Reference: 6586320; Size: L Platform: L; TiBase AT EV 4.8 GH 1 L; Reference: 6586338; Size: L

Manufacturer: Dentsply Sirona Implant

Implant: AstraTech OsseoSpeed TX

Platform 3.5 / 4.0; TiBase AT TX 3.5/4.0 GH 1 L; Reference: 6598093; Size: L Platform 4.5 / 5.0; TiBase AT TX 4.5/5.0 GH 1 L; Reference: 6598101; Size: L Platform 3.5 / 4.0; TiBase AT OS 3.5/4.0 GH 1 L; Reference: 6282532; Size: L Platform 4.5 / 5.0; TiBase AT OS 4.5/5.0 GH 1 L; Reference: 6282540; Size: L

Manufacturer: Dentsply Sirona Implant Implant: Frialit / XiVE Platform: 3.4; TiBase FX 3.4 GH 1 S; Reference: 6282433; Size: S

4

Platform: 3.8; TiBase FX 3.8 GH 1 S; Reference: 6282441; Size: S Platform: 4.5; TiBase FX 4.5 GH 1 L; Reference: 6282458; Size: L Platform: 5.5; TiBase FX 5.5 GH 1 L; Reference: 6282466; Size: L

Manufacturer: Dentsply Sirona Implant Implant: AstraTech Implant EV Platform: XL; TiBase AT EV 5.4 GH 1 L; Reference: 66586346; Size: L

Manufacturer: Dentsply Sirona Implant

Implant: Ankylos Platform: C/X; TiBase ANK C/ GH 1 S; Reference: 6586528; Size: S Platform: C/X; TiBase ANK C/ GH 2 S; Reference: 6586536; Size: S Platform: C/X; TiBase ANK /X GH 1 S; Reference: 6586544; Size: S Platform: C/X: TiBase ANK /X GH 2 S; Reference: 6586551; Size: S

Manufacturer: BioHorizons

Implant: Internal Connection

Platform: 3.0; TiBase BH 3.0 GH 1 S; Reference: 6532779; Size: S

Platform: 3.5; TiBase BH 3.5 GH 1 L; Reference: 6532894; Size: L

Platform: 4.5; TiBase BH 4.5 GH 1 L; Reference: 6532951; Size: L

Platform: 5.7; TiBase BH 5.7 GH 1 L; Reference: 6536242; Size: L

Manufacturer: Nobel Biocare

Implant: Replace, Replace Select

Platform: NP; TiBase NB RS 3.5 GH 1 L; Reference: 6282474; Size: L Platform: RP; TiBase NB RS 4.3 GH 1 L; Reference: 6282482; Size: L Platform: WP; TiBase NB RS 5.0 GH 1 L; Reference: 6282490; Size: L Platform: 6.0; TiBase NB RS 6.0 GH 1 L; Reference: 6282508; Size: L

Implant: Nobel Active Platform: NP; TiBase NB A 4.5 GH 1 L; Reference: 6308188; Size: L

Implant: NobelReplace Conical Connection Platform: RP; TiBase NB A 5.0 GH 1 L; Reference: 6308253; Size: L

Implant: Brånemark Platform: NP, TiBase NB B 3.4 GH 1 L; Reference: 6282516; Size: L

Implant: NobelSpeedy Groovy Platform: RP; TiBase NB B 4.1 GH 1 L; Reference: 6282524; Size: L

Manufacturer: Straumann Implant: Tissue Level Platform: RN (4.8 mm): TiBase SSO 4.8 GH 1 L: Reference: 6284249; Size: L Platform: WN (6.5 mm); TiBase SSO 6.5 GH 1 L; Reference: 6284256; Size: L

Implant: Bone Level Platform: NC (3.3 mm); TiBase S BL 3.3 GH 1 L; Reference: 6308154; Size: L Platform: RC (4.1 mm / 4.8 mm); TiBase S BL C 4.1 GH 1 L; Reference: 6308337; Size: L

Manufacturer: Thommen Medical Implant: Element, Contact Platform: 3.5; TiBase TM 3.5 GH 1 S; Reference: 6531854; Size: S Platform: 4; TiBase TM 4 GH 1 S; Reference: 6532829; Size: S

5

Platform: 4.5; TiBase TM 4.5 GH 1 S; Reference: 6532837; Size: S Platform: 5; TiBase TM 5 GH 1 S; Reference: 6544360; Size: S Platform: 6; TiBase TM 6 GH 1 S; Reference: 6544378; Size: S

Manufacturer: Osstem / Hiossen Implant: Osstem TS (US Hiossen ET) Platform: Mini; TiBase O TS 3.5 GH 1 L; Reference: 6527035; Size: L Platform: Regular; TiBase O TS 4.0 GH 1 L; Reference: 6527043; Size: L

Manufacturer: Zimmer / Biomet Implant: External hex Platform: 3.4; TiBase B O 3.4 GH 1 L; Reference: 6282557; Size: L Platform: 4.1; TiBase B O 4.1 GH 1 L; Reference: 6282565; Size: L Platform: 5.0; TiBase B O 5.0 GH 1 L; Reference: 6282573; Size: L

Implant: Certain

Platform: 3.4; TiBase B C 3.4 GH 1 S; Reference: 6308048; Size: S Platform: 4.1; TiBase B C 4.1 GH 1 L; Reference: 6308097; Size: L Platform: 5.0; TiBase B C 5.0 GH 1 L; Reference: 6308121; Size: L

Implant: Tapered Screw-Vent

Platform: 3.5; TiBase Z TSV 3.5 GH 1 L; Reference: 6282581; Size: L Platform: 4.5; TiBase Z TSV 4.5 GH 1 L; Reference: 6282599; Size: L Platform: 5.7; TiBase Z TSV 5.7 GH 1 L; Reference: 6282607; Size: L

Manufacturer: M.I.S. Implants

Implant: C1 Conical Connection

Platform: NP; TiBase CN-TB001 C1 NP GH 0.5; Reference: CN-TB001; Size: L Platform: NP: TiBase CN-B015 C1 NP GH 1.5; Reference: CN-TB015; Size: L

Implant: V3 Conical Connection

Platform: NP; TiBase VN-TB001 V3 NP GH 0.5; Reference: VN-TB001; Size: L Platform: NP; TiBase VN-TB015 V3 NP GH 1.5; Reference: VN-TB015; Size: L

Implant: V3 Conical Connection / C1 Conical Connection Platform: SP; TiBase CS-TB001 SP GH 0.5; Reference: CS-TB001; Size: L Platform: SP; TiBase CS-TB015 SP GH 1.5; Reference: CS-TB015; Size: L Platform: SP; TiBase CS-TB030 SP GH 3; Reference: CS-TB030; Size: L

Implant: C1 Conical Connection

Platform: WP; TiBase CW-TB001 C1 WP GH 0.5; Reference: CW-TB001; Size: L Platform: WP; TiBase CW-TB015 C1 WP GH 1.5; Reference: CW-TB015; Size: L Platform: WP; TiBase CW-TB030 C1 WP GH 3; Reference: CW-TB030; Size: L

Implant: SEVEN internal hex, M4 internal hex

Platform: NP; TiBase MN-TB001 INT HEX NP GH 0.5; Reference: MN-TB001; Size: L Platform: NP; TiBase MN-TBC15 INT HEX NP GH 1.5; Reference: MN-TBC15; Size: L Platform: SP; TiBase MD-TB001 INT HEX SP GH 0.5; Reference: MD-TB001; Size: L Platform: SP; TiBase MD-TBC15 INT HEX SP GH 1.5; Reference: MD-TBC15; Size: L Platform: SP; TiBase MD-TBC30 INT HEX SP GH 3; Reference: MD-TBC30; Size: L Platform: WP; TiBase MW-TB001 INT HEX WP GH 0.5; Reference: MW-TB001; Size: L Platform: WP; TiBase MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L Platform: WP; TiBase MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L

6

Manufacturer: Straumann Implant: Tissue Level Platform: NNC (3.5 mm); TiBase NNC Variobase C 3.5 GH 1; Reference: 220.018; Size: S Platform: RN (4.8 mm): TiBase RN Varionbase C 3.5 GH 1; Reference: 220.019; Size: L Platform: WN (6.5 mm); TiBase WN Variobase C GH 1; Reference: 220.020; Size: L

Implant: Bone Level Platform: NC (3.3 mm); TiBase NC Variobase C 3.3 GH 1; Reference: 220.043; Size: S Platform: RC (4.1 mm / 4.8 mm); TiBase RC Variobase C 4.1 GH 1; Reference: 220.044; Size: L

Manufacturer: Altatec GmbH-Camlog

Implant: Camlog

Platform: 3.3; CAMLOG Titanium Base CADM/CAM, for Ø 3.3 mm GH 0.4; Reference K2244.3348; Size S Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for Ø 3.8 mm GH 0.3; Reference: K2244.3848; Size: S Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for Ø 4.3 mm GH 0.3; Reference: K2244.4348; Size: S Platform: 5.0; CAMLOG Titanium Base CAD/CAM, for Ø 5.0 mm GH 0.3; Reference K2244.5048; Size: L Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for Ø 6.0 mm GH 0.3; Reference K2244.6048; Size: L

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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7

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

Image /page/7/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a blue abstract shape on the left and the words "Dentsply Sirona" in blue on the right. The abstract shape is made up of two curved lines that form an S shape. The text is in a sans-serif font.

510(k) SUMMARY

for

CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018)

    1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Contact Person:Rebecca Sporer
Telephone Number:717-849-4793
Email:Corporate-RA@dentsplysirona.com
Date Prepared:02 May 2024
    1. Device Name:
    • CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Proprietary Name: ●
      • Abutment System
    • Classification Name: Endosseous dental implant abutment
    • 872.3630 ● CFR Number:
    • . Device Class: Class II
    • Primary Product Code: NHA .
    • . Secondary Product Code: PNP

3. Predicate/Reference Devices:

Predicate Device Name510(k)Company Name
CEREC Tessera Abutment Block, CEREC Tessera
Abutment SystemK221402Dentsply Sirona
Reference Device Name510(k)Company Name
Technological characteristics / Performance / Composition / Biocompatibility
Sirona Dental CAD/CAM System (inCoris ZI meso material)K111421Dentsply Sirona
Material Composition / Biocompatibility Only
CerconK162888Dentsply Sirona
Reverse Engineering Compatibility Testing
Sirona Dental CAD/CAM System with inLab SoftwareK200191Dentsply Sirona
Sirona Dental CAD/CAM System with CEREC Chairside SoftwareK193408Dentsply Sirona
Sirona Dental CAD/CAM SystemK181520Dentsply Sirona
Sirona Dental CAD/CAM SystemK100152Dentsply Sirona

8

Compatible Dental Implants510(k)Company Name
PrimeTaper EVK210610Dentsply Sirona
OmniTaper EVK221094Dentsply Sirona
AstraTech OsseoSpeed TXK053384Dentsply Sirona
Frialit/ XiVEK013867Dentsply Sirona
AstraTech Implant EVK120414Dentsply Sirona
AnkylosK083805Dentsply Sirona
Internal ConnectionK143022,
K071638,
K093321,
K042429BioHorizons
Replace, Replace SelectK020646Nobel Biocare
Nobel Active and NobelReplace Conical ConnectionK071370Nobel Biocare
Branemark and NobelSpeedy GroovyK022562Nobel Biocare
Straumann Tissue Level and Bone LevelK151324Straumann
Element, ContactK093615,
K090154Thommen Medical
Osstem TS (Hiossen ET)K121585Osstem/Hiossen
External Hex, Certain and Tapered Screw-VentK061410,
K061629,
K014235Zimmer/Biomet
C1 Conical Connection, V3 Conical Connection,
SEVEN internal hex and M4 internal hexK191152Dentsply Sirona
CamlogK083496Altatec GmbH

4. Description of Device:

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to the TiBase (Titanium base) used with dental implant systems. The following patient-specific ranges for CAD/CAM fabrication of the subject abutments are:

  • . Maximum angulation of 200
  • . Minimal wall thickness of 0.5 mm
  • Gingival height ranges from 0.3-2.0 mm ●
  • Minimum abutment post height (i.e. length above the gingival height) of ≥ 4 mm .

9

    1. Indications for Use:
      CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

  • CEREC Cercon 4D™ Abutment Block
  • TiBase
  • CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for twopiece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Implant Systems:

  • Dentsply Sirona: PrimeTaper EV, OmniTaper EV, AstraTech OsseoSpeed TX, . Frialit / XiVE , AstraTech Implant EV , Ankylos
  • BioHorizons: Internal connection .
  • Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Conical . Connection, Brånemark, NobelSpeedy Groovy
  • Straumann: Tissue Level, Bone Level ●
  • Thommen Medical: Element, Contact
  • Osstem/Hiossen: Osstem TS, USA:Hiossen ET
  • Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent ●
  • MIS: C1 Conical Connection, V3 Conical Connection, SEVEN internal hex, M4 ● internal hex
  • . Altatec - Camlog

CAD/CAM Systems:

  • Sirona Dental CAD/CAM System .

10

Compatible TiBase and Implant Systems

Implant SystemTitanium Base
Manufacturer / linePlatformNameREFSize
Dentsply Sirona ImplantsSTiBase AT EV 3.6 GH 1 S6586312S
Primetaper EVMTiBase AT EV 4.2 GH 1 L6586320L
LTiBase AT EV 4.8 GH 1 L6586338L
3.5 / 4.0TiBase AT TX 3.5/4.0 GH 1 L6598093L
AstraTech
OsseoSpeed TX4.5 / 5.0TiBase AT TX 4.5/5.0 GH 1 L6598101L
3.5 / 4.0TiBase AT OS 3.5/4.0 GH 1 L6282532L
4.5 / 5.0TiBase AT OS 4.5/5.0 GH 1 L6282540L
Frialit / Xive3.4TiBase FX 3.4 GH 1 S6282433S
3.8TiBase FX 3.8 GH 1 S6282441S
4.5TiBase FX 4.5 GH 1 L6282458L
5.5TiBase FX 5.5 GH 1 L6282466L
AstraTech Implant
EVXLTiBase AT EV 5.4 GH 1 L6586346L
AnkylosC/XTiBase ANK C/ GH 1 S6586528S
TiBase ANK C/ GH 2 S6586536S
TiBase ANK /X GH 1 S6586544S
TiBase ANK /X GH 2 S6586551S
BioHorizons
Internal connection3.0TiBase BH 3.0 GH 1 S6532779S
3.5TiBase BH 3.5 GH 1 L6532894L
4.5TiBase BH 4.5 GH 1 L6532951L
5.7TiBase BH 5.7 GH 1 L6536242L
Nobel Biocare
Replace, Replace
SelectNPTiBase NB RS 3.5 GH 1 L6282474L
RPTiBase NB RS 4.3 GH 1 L6282482L
WPTiBase NB RS 5.0 GH 1 L6282490L
6.0TiBase NB RS 6.0 GH 1 L6282508L
Nobel ActiveNPTiBase NB A 4.5 GH 1 L6308188L
NobelReplace
Conical ConnectionRPTiBase NB A 5.0 GH 1 L6308253L
BrånemarkNPTiBase NB B 3.4 GH 1 L6282516L
NobelSpeedy
GroovyRPTiBase NB B 4.1 GH 1 L6282524L
Straumann
Tissue LevelRN (4.8 mm)TiBase SSO 4.8 GH 1 L6284249L
WN (6.5 mm)TiBase SSO 6.5 GH 1 L6284256L
Bone LevelNC (3.3 mm)TiBase S BL 3.3 GH 1 L6308154L
RC (4.1 mm / 4.8 mm)TiBase S BL 4.1 GH 1 L6308337L
Thommen Medical
Element, Contact3.5TiBase TM 3.5 GH 1 S6531854S
4TiBase TM 4 GH 1 S6532829S
4.5TiBase TM 4.5 GH 1 S6532837S
5TiBase TM 5 GH 1 S6544360S
6TiBase TM 6 GH 1 S6544378S
Implant SystemTitanium Base
Manufacturer / linePlatformNameREFSize
Osstem / Hiossen
Osstem TSMiniTiBase O TS 3.5 GH 1 L6527035L
(USA: Hiossen ET)RegularTiBase O TS 4.0 GH 1 L6527043L
Zimmer /Biomet
3.4TiBase B O 3.4 GH 1 L6282557L
External hex4.1TiBase B O 4.1 GH 1 L6282565L
5.0TiBase B O 5.0 GH 1 L6282573L
3.4TiBase B C 3.4 GH 1 S6308048S
Certain4.1TiBase B C 4.1 GH 1 L6308097L
5.0TiBase B C 5.0 GH 1 L6308121L
3.5TiBase Z TSV 3.5 GH 1 L6282581L
Tapered Screw-Vent4.5TiBase Z TSV 4.5 GH 1 L6282599L
5.7TiBase Z TSV 5.7 GH 1 L6282607L
M.I.S
C1 ConicalNPCN-TB001 C1 NP GH 0.5CN-TB001L
ConnectionCN-TB015 C1 NP GH 1.5CN-TB015L
V3 ConicalVN-TB001 V3 NP GH 0.5VN-TB001L
ConnectionNPVN-TB015 V3 NP GH 1.5VN-TB015L
V3 ConicalCS-TB001 SP GH 0.5CS-TB001L
Connection, C1SPCS-TB015 SP GH 1.5CS-TB015L
Conical ConnectionCS-TB030 SP GH 3CS-TB030L
CW-TB001 C1 WP GH 0.5CW-TB001L
C1 Conical
ConnectionWPCW-TB015 C1 WP GH 1.5CW-TB015L
CW-TB030 C1 WP GH 3CW-TB030L
MN-TB001 INT HEX NP GH 0.5MN-TB001L
NPMN-TBC15 INT HEX NP GH 1.5MN-TBC15L
MD-TB001 INT HEX SP GH 0.5MD-TB001L
SEVEN internal hex,
M4 internal hexSPMD-TBC15 INT HEX SP GH 1.5MD-TBC15L
MD-TBC30 INT HEX SP GH 3MD-TBC30L
WPMW-TB001 INT HEX WP GH 0.5MW-TB001L
MW-TBC15 INT HEX WP GH 1.5MW-TBC15L
MW-TBC30 INT HEX WP GH 3MW-TBC30L
Straumann
NNC (3.5 mm)NNC Variobase C 3.5 GH 1220.018S
Tissue LevelRN (4.8 mm)RN Variobase C GH 1220.019L
WN (6.5 mm)WN Variobase C GH 1220.020L
Bone LevelNC (3.3 mm)NC Variobase C 3.3 GH 1220.043S
RC (4.1 mm / 4.8 mm)RC Variobase C 4.1 GH 1220.044L
Camlog
3.3CAMLOG® Titanium base CAD/CAM, for Ø 3.3 mm GH
0.4K2244.3348S
Camlog3.8CAMLOG® Titanium base CAD/CAM ,for Ø 3.8 mm GH
0.3K2244.3848S
4.3CAMLOG® Titanium base CAD/CAM, for Ø 4.3 mm GH
0.3K2244.4348S
5.0CAMLOG® Titanium base CAD/CAM, for Ø 5.0 mm GH
0.3K2244.5048L
6.0CAMLOG® Titanium base CAD/CAM, for Ø 6.0 mm GH
0.3K2244.6048L

11

12

Substantial Equivalence: 6.

The indications for use of the proposed device do not constitute a new intended use. The proposed CEREC Cercon 4D™ Abutment Block has the same intended use and similar indications for use compared to the predicate, CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and reference device Sirona Dental CAD/CAM System (inCoris ZI meso material) (K111421) in that they are used with TiBases, Implant Systems and CAD/CAM technology. The main difference is the compatible Implant systems and titanium bases. The block material and TiBase make up an a 2-piece hybrid abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. Table 6.2 compare the Intended Use and Indications for Use when compared to the predicate and reference devices.

Table 6.1-Comparison of Intended Use
CEREC Cercon 4D™ Abutment
Blocks, CEREC Cercon 4DTM
Abutment System (K234018)Predicate Device
CEREC Tessera Abutment Block,
CEREC Tessera Abutment System
(K221402)Reference Device
Sirona Dental CAD/CAM System
(inCoris ZI meso material)
(K111421)Discussion
CEREC Cercon 4D™ Abutment
Blocks are a ceramic intended for
fixed dental prosthetic restorations.CEREC Tessera Abutment Blocks are a
ceramic intended for fixed dental
prosthetic restorations.inCoris ZI meso blocks are intended for use
in manufacturing individually designed
mesostructures, which are glued to a fitting
titanium base after milling and sintering.The proposed and predicate
device have the same Intended
Use.
The Intended Use of the
reference device is similar to
Intended Use of the proposed
and predicate devices in that the
mesostructure is cemented to the
titanium base as part of a two-
piece hybrid abutment.
Table 6.2 - Comparison of Indications for Use
CEREC Cercon 4D™ Abutment
Blocks, CEREC Cercon 4DTM
Abutment System (K234018)Predicate Device
CEREC Tessera Abutment Block,
CEREC Tessera Abutment System
(K221402)Reference Device
Sirona Dental CAD/CAM System
(inCoris ZI meso material)
(K111421)Discussion
CEREC Cercon 4D™ Abutment
System is intended for use in
partially or fully edentulous
mandibles and maxillae in support
of single cement-retained
restorations.
The system comprises three parts:
• CEREC Cercon 4D™ Abutment
Block
• TiBases
• CAD/CAM systemCEREC Tessera Abutment System is
intended for use in partially or fully
edentulous mandibles and maxillae in
support of single cement-retained
restorations.
The system comprises three parts:
  • CEREC Tessera Abutment Block
  • TiBase
  • CAD/CAM system | The Sirona Dental CAD/CAM System is
    intended for use in partially or fully
    edentulous mandibles and maxillae in
    support of single or multiple-unit cement
    retained restorations. The system consists of
    three major parts: TiBase, InCoris
    mesostructure, and CAD/CAM software. | Same as predicate and
    reference devices.
    The reference device is
    additionally indicated for
    multiple-unit cement
    retained restorations which
    pertains to other materials
    used within the CAD/CAM
    system. | |
    | The CEREC Cercon 4D™ ceramic
    structure cemented to the TiBase is
    recommended for two-piece hybrid
    abutments for single tooth
    restorations and hybrid abutment
    crowns, used in conjunction with
    endosseous dental implants. | The CEREC Tessera ceramic structure
    cemented to the TiBase is recommended for
    two-piece hybrid abutments for single tooth
    restorations and hybrid abutment crowns,
    used in conjunction with endosseous dental
    implants. | Specifically, the InCoris mesostructure and
    TiBase components make up a two-piece
    abutment which is used in conjunction with
    endosseous dental implants to restore the
    function and aesthetics in the oral cavity. The
    InCoris mesostructure may also be used in
    conjunction with the Camlog Titanium base
    CAD/CAM (types K2244.xxxx) (K083496)
    in the Camlog Implant System. The
    CAD/CAM software is intended to design
    and fabricate the InCoris mesostructure. | The proposed and predicate
    devices are the same.
    The reference device is
    similar with an additional
    use with Camlog Implant
    System and Titanium base.
    The proposed block is also
    indicated for use with the
    Camlog (3rd party products).
    Fatigue testing to support the
    use with 3rd party implant
    systems and TiBases is
    included in the Performance
    Bench Testing section. | |
    | Table 6.2 - Comparison of Indications for Use | | | | |
    | CEREC Cercon 4D™ Abutment
    Blocks, CEREC Cercon 4D™
    Abutment System (K234018) | Predicate Device
    CEREC Tessera Abutment Block,
    CEREC Tessera Abutment System
    (K221402) | Reference Device
    Sirona Dental CAD/CAM System
    (inCoris ZI meso material)
    (K111421) | Discussion | |
    | Implant Systems:
    • Dentsply Sirona: PrimeTaper EV,
    OmniTaper EV, AstraTech
    OsseoSpeed TX, Frialit / XiVE,
    AstraTech Implant EV, Ankylos
    • BioHorizons: Internal connection
    • Nobel Biocare: Replace, Replace
    Select, Nobel Active,
    NobelReplace Conical
    Connection , Brånemark,
    NobelSpeedy Groovy
    • Straumann: Tissue Level, Bone
    Level
    • Thommen Medical: Element,
    Contact
    • Osstem/Hiossen: Osstem TS
    , USA:Hiossen ET
    • Zimmer/Biomet: External hex,
    Certain, Tapered Screw-Vent
    • MIS: C1 Conical
    Connection, V3 Conical
    Connection, SEVEN | The compatible Implant systems, titanium
    bases and CAD/CAM systems are shown
    below:
    Implant Systems:
    • Dentsply Sirona: AstraTech OsseoSpeed
    TX (K053384), XiVE (K013867),
    AstraTech Implant EV (K120414),
    Ankylos (K083805), PrimeTaper EV
    (K210610)
    • MIS: C1 Conical connection (K172505
    NP, K180282 WP), V3 Conical connection
    (K163349), SEVEN internal hex
    (K112162), M4 internal hex (K112162)
    CAD/CAM Systems:
    • Sirona Dental CAD/CAM System
    (K193408, K200191)
    Titanium Bases:
    • Refer to Table 6.2a for the
    compatible Titanium Bases | The InCoris mesostructure and TiBase two-
    piece abutment is compatible with the
    following implant systems:
    • Nobel Biocare Replace (K020646)
    • Nobel Biocare Branemark (K022562)
    • Friadent Xive (K001386)
    • Biomet 3i Osseotite (K980549)
    • Astra Tech Osseospeed (K091239)
    • Zimmer Tapered Screw-Vent (K061410)
    • Straumann SynOcta (K061176)
    • Straumann Bone Level (K053088)
    • Biomet 3i Certain (K014235)
    • Nobel Biocare Active (K071370) | Proposed device does not
    include implant system or
    titanium bases in the
    Indications for Use
    statement. Instead, a
    compatibility table for the
    Implant Systems and
    TiBases is included within
    the Instructions for Use
    (IFU). | |
    | Table 6.2 - Comparison of Indications for Use | | | | |
    | CEREC Cercon 4D™ Abutment
    Blocks, CEREC Cercon 4D™
    Abutment System (K234018) | Predicate Device
    CEREC Tessera Abutment Block,
    CEREC Tessera Abutment System
    (K221402) | Reference Device
    Sirona Dental CAD/CAM System
    (inCoris ZI meso material)
    (K111421) | Discussion | |
    | internal hex, M4 internal hex | | | | |
    | • Altatec – Camlog | | | | |
    | CAD/CAM Systems: | | | | |
    | • Sirona Dental CAD/CAM System | | | | |
    | Refer to compatible Titanium Bases | | | | |
    | and Implant Systems Table above | | | | |
    | in the Indications for Use-Section 5. | | | | |
    | Table 6.2a- Compatibility Table included in the Predicate Device Indications for Use Statement above | | | | |
    | Implant system | | Titanium base | | |
    | Manufacturer / line | Platform | Name | REF | Size |
    | Dentsply Sirona Implants | | | | |
    | AstraTech OsseoSpeed TX | 3.5 / 4.0 | TiBase AT OS 3.5/4.0 L | 6282532 | L |
    | (K053384) | 4.5 / 5.0 | TiBase AT OS 4.5/5.0 L | 6282540 | L |
    | | 3.5 / 4.0 | TiBase AT TX 3.5/4.0 L | 6598093 | L |
    | | 4.5 / 5.0 | TiBase AT TX 4.5/5.0 L | 6598101 | L |
    | XiVE (K013867) | 3.4 | TiBase FX 3.4 S | 6282433 | S |
    | | 3.8 | TiBase FX 3.8 S | 6282441 | S |
    | | 4.5 | TiBase FX 4.5 L | 6282458 | L |
    | | 5.5 | TiBase FX 5.5 L | 6282466 | L |
    | AstraTech Implant EV | S | TiBase AT EV 3.6 GH1 S | 6586312 | S |
    | (K120414) | M | TiBase AT EV 4.2 GH1 L | 6586320 | L |
    | Prime Taper EV (K210610) | L | TiBase AT EV 4.8 GH1 L | 6586338 | L |
    | AstraTech Implant EV
    (K120414) | XL | TiBase AT EV 5.4 GH1 L | 6586346 | L |
    | Ankylos (K083805) | | TiBase ANK C/ GH1 S | 6586528 | S |
    | | C/X | TiBase ANK C/ GH2 S | 6586536 | S |
    | | | TiBase ANK /X GH1 S | 6586544 | S |
    | | | TiBase ANK /X GH2 S | 6586551 | S |
    | M.I.S. Implants | | | | |
    | C1 Conical Connection | NP | CN-TB001 C1 NP GH 0.5 | CN-TB001 | L |
    | (K172505) | | CN-TB015 C1 NP GH 1.5 | CN-TB015 | L |
    | V3 Conical Connection | NP | VN-TB001 V3 NP GH 0.5 | VN-TB001 | L |
    | (K163349) | | VN-TB015 V3 NP GH 1.5 | VN-TB015 | L |
    | SEVEN internal hex, M4 internal | NP | MN-TB001 INT HEX NP GH 0.5 | MN-TB001 | L |
    | hex (K112162) | | MN-TBC15 INT HEX NP GH 1.5 | MN-TBC15 | L |
    | | SP | MD-TB001 INT HEX SP GH 0.5 | MD-TB001 | L |
    | | | MD-TBC15 INT HEX SP GH 1.5 | MD-TBC15 | L |
    | | | MD-TBC30 INT HEX SP GH 3 | MD-TBC30 | L |
    | | WP | MW-TB001 INT HEX WP GH 0.5 | MW-TB001 | L |
    | | | MW-TBC15 INT HEX WP GH 1.5 | MW-TBC15 | L |
    | | | MW-TBC30 INT HEX WP GH 3 | MW-TBC30 | L |

13

14

15

16

17

7. Technological Comparison:

The proposed CEREC Cercon 4D™ Abutment Block is similar in intended use, design, principles of operation and meet the requirements of ISO 14801:2016 compared to the predicate device CEREC Tessera Abutment Block, CEREC Tessers Abutment System (K221402) and the reference device Sirona Dental CAD/CAM System (inCoris ZI meso) (K111421). The only difference between the proposed, predicate and reference devices is the material. The proposed and reference devices are zirconia material, whereas the predicate is an advanced lithium disilicate material. Table 7.1 compares the technological characteristics of the proposed device compared to the predicate and reference devices.

| Table 7.1: Comparison between the proposed CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System, the predicate

device CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and reference device inCoris ZI meso (K111421)
Item of
ComparisonProposed Device
CEREC Cercon 4D™
Abutment Blocks, CEREC
Cercon 4D™ Abutment
System (K234018)Predicate Device
CEREC Tessera Abutment
Block, CEREC Tessera
Abutment System
(K221402)Reference Device
Sirona Dental CAD/CAM
System
(inCoris ZI meso
material)
(K111421)Similarities and Differences
Product CodePrimary: NHA
Secondary: PNPPrimary: NHA
Secondary: PNPNHASame to the predicate device
and similar to the reference
device
ManufacturerDentsply SironaDentsply SironaDentsply SironaSame
Abutment Angle0° to 20°0° to 20°0° to 20°Same
RestorationSingle UnitSingle UnitSingle UnitSame
MaterialZirconia1Advanced Lithium DisilicateZirconia1The proposed and reference
device are both zirconia
materials. The predicate device
differs in material.
Cement
(Adhesive/Glue)Calibra Abutment
CementCalibra CementNo specific cement
referencedSimilar, the role of the cement is
to glue the crown or meso-
structure to the TiBase
SterilityNon-SterileNon-SterileNon-SterileSame
Table 7.1: Comparison between the proposed CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System, the predicate device CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and reference device inCoris ZI meso (K111421)
Item of ComparisonProposed Device
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018)Predicate Device
CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402)Reference Device
Sirona Dental CAD/CAM System (inCoris ZI meso material) (K111421)Similarities and Differences
Sterilization MethodSteam Sterilization (final, assembled prosthetic restoration)Steam Sterilization (final, assembled prosthetic restoration)Steam sterilization (final, assembled prosthetic restoration)Same
BiocompatibilityMeets ISO 10993 requirementsMeets ISO 10993 requirementsMeets ISO 10993 requirementsSame
FatigueMeets ISO 14801 requirementsMeets ISO 14801 requirementsMeets ISO 14801 requirementsSame
Flexural StrengthMeets ISO 6872:2015 (Amd 1. 2018) requirementsMeets ISO 6872:2015 (Amd 1. 2018) requirementsMeets ISO 6872:2015 (Amd 1. 2018) requirementsSame
Software VerificationMeets internal software integration requirements for the addition of the proposed device CEREC Cercon 4D Abutment BlocksMeets internal software integration requirements for the addition of the CEREC Tessera Abutment BlockMeets internal software integration requirements for the addition of the inCoris ZI mesoSame. The proposed, predicate and reference devices have all been integrated into the compatible Sirona CAD/CAM System software (K193408, K200191).
DesignImage: CEREC Cercon 4D AbutmentImage: CEREC Tessera AbutmentImage: Sirona inCoris ZI mesoSame.
The proposed, predicate and reference devices are all shaped like a block and have a screw access channel.
MRI Safety LabelingMRI ConditionalMRI Conditional---Same as predicate

1 Yttrium Oxice is present in the proposed device Cercon 4D" Abutnent Blocks as well as the reference devices inCoris ZI meso material (K111421) and Cercon® (K16288). Component concentrations in the formulation are similar to those of the reference devices " tormulations and support biocompatibility (refer to the Biocompatibility section).

18

19

8. Non-Clinical Tests Summary and Conclusion:

Performance Testing:

The proposed device was tested and conforms to ISO 6872:2015 (Amd 1. 2018) Dentistry-Ceramic Materials and ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants. Additionally, software system verification was performed as part of the non-clinical testing. Table 8.1 summarizes the performance bench testing for flexural strength conducted on the proposed device according to ISO 6872:2015 (Amd 1. 2018). Table 8.2 summarizes the performance bench testing for fatigue strength according to ISO 14801:2016. New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations. The testing conducted together with historical data on file for the reference device (K111421) was leveraged to support performance of Dentsply Sirona TiBase/Third Party Implant Systems, and Dentsply Sirona TiBase/Dentsply Sirona Implant Systems, and Third Party TiBase/Third Party Implant Systems combinations.

Table 8.1- Performance Specifications-Flexural Strength
Test PerformedTest method/Applicable StandardsAcceptance
CriteriaResults
Flexural Strength
(3-point bending strength)ISO 6872:2015 Amd 1. 2018
Dentistry-Ceramic Materials>1,100 MPaPass
Table 8.2- Performance Specifications-Fatigue Strength
Test PerformedTest method/Applicable
StandardsResults
Fatigue Testing after steam sterilization- MIS
Narrow Platform conical connection C1-10330
with CN-TB015 TiBasePass
Fatigue Testing after steam sterilization- MIS
Standard Platform conical connection C1-08375
with CS-TB030 TiBaseISO 14801:2016 Dentistry-
Implants-Dynamic loadingPass
Fatigue Testing after steam sterilization- DS
XiVE S Plus implant D3.4/L15 with DS TiBase
FX 3.4 Stest for endosseous dental
implantsPass
Fatigue Testing after steam sterilization- Camlog
Screw-Line Implant nominal size 3.8mm length
13.mm with Camlog Titanium Base CAD/CAMPass

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Cleaning, Disinfection, and Sterilization Testing:

Sterilization validation testing was conducted in accordance with ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The validation process was validated using a hybrid method to ensure that the proposed device can be steam sterilized and achieve a Sterility Assurance Level (SAL) of 106 in support of the following dynamic air removal (pre-vacuum) steam sterilization parameters:

  • . 132°C (270°F) for 4 minutes; Dry Time=20 minutes
  • . 135°C (275°F) for 3 minutes; Dry Time=16 minutes

CAD/CAM Software Validation & Verification Testing:

Software validation was performed to show the maximum and minimum design parameters for the CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System within the compatible CAD/CAM software. The following parameters are locked into the CAD/CAM software libraries:

  • . Maximum angulation of 20°
  • . Minimal wall thickness of 0.5 mm

The angulation within the CAD/CAM system is fixed and set across all libraries. If the user choses an angulation outside the set value, they will get an error screen that is red in color that indicates a "stop" and the user will not be able to proceed without updating the design to meet the angulation set within the system.

The wall thickness parameter is defined in the CAD/CAM library for the material itself. Ifthe user choses a wall thickness outside the defined parameter, they will get an error screen and will not be able to proceed without updating the design to meet the wall thickness parameter.

Adding implant/abutment compatibilities to the CAD/CAM library is restricted by the implant/abutment manufacturer's assigned parameters. The gingival height (GH) is defined by the TiBase chosen and there is no option within the CAD/CAM system to change the GH. The TiBase chosen also defines the post height (PH) which is a restricted value set by the manufacturer of the TiBase. Once the TiBase is chosen for that material the GH and PH are defined and cannot be altered by the user during the design phase. When a new implant/TiBase is added to the CAD/CAM library, the manufacturer provides Dentsply Sirona with those parameters and a separate verification is conducted. Third-party compatibilities are added through the device master file system.

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Biocompatibility Testing:

A biological risk assessment was conducted on the proposed device, CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System. Review of available information on raw materials, manufacturing processes, chemical characterization tests and existing preclinical biological testing data concludes that the test results meet the requirements of the following ISO 10993 standard series.

The following tests were conducted:

  • . Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5 Test for In Vitro Cytotoxicity)
  • Sensitization (ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10 Test . for Skin Sensitization)

. Irritation (ISO 10993-23:2021 Biological Evaluation of Medical Devices-Part 23 Test for Irritation)

Conclusion:

Minor differences in the technological characteristics between the proposed and predicate (K221402) devices were evaluated through appropriate fatigue testing, performance bench testing, software validation and verification, and biocompatibility testing, which demonstrated that the proposed device, when compared to the predicate device, does not raise new questions regarding safety and effectiveness. Therefore, the nonclinical testing data supports the conclusion that the proposed device performs as well as the predicate device (K221402).

9. Clinical Tests Summary and Conclusion:

Not applicable. No data from human clinical studies has been included to support the substantial equivalence of CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System.

10. Conclusion Regarding Substantial Equivalence:

The proposed CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System has the same Intended Use and nearly identical Indications for Use as compared to the predicate device, CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and the reference device, Sirona Dental CAD/CAM System (inCoris ZI meso material (K111421)). The proposed, predicate and reference devices also share the same fundamental technology. The reference devices, Sirona Dental CAD/CAM System (inCoris ZI meso material (K111421)) and Cercon (K162888) are similar in material composition when compared to the proposed device. Test data is included in this premarket notification to verify the safety and performance requirements of the proposed device and the results support a conclusion of substantial equivalence.