(139 days)
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.
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.
The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.
Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.
Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Test Method/Applicable Standards | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Flexural Strength | ISO 6872:2015 Amd 1. 2018 Dentistry-Ceramic Materials | >1,100 MPa | Pass |
| Fatigue Testing | ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants | (Implied: Meets requirements) | Pass |
| Sterilization Validation | 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 | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ | Validated |
| Biocompatibility | ISO 10993 standard series (specifically ISO 10993-5, -10, -23) | Meets ISO 10993 requirements | Meets requirements |
| Software Validation (Angulation) | Internal software integration requirements for the addition of the proposed device | Max angulation of 20° (User cannot proceed if outside) | Meets requirements |
| Software Validation (Wall Thickness) | Internal software integration requirements for the addition of the proposed device | Minimal wall thickness of 0.5 mm (User cannot proceed if outside) | Meets requirements |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
- For Fatigue Testing (Table 8.2): "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 exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
- For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device; therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not have a "training set" in the context of machine learning.
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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.
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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.
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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
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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
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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
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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
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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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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)
-
- 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 |
-
- 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 Name | 510(k) | Company Name |
|---|---|---|
| CEREC Tessera Abutment Block, CEREC TesseraAbutment System | K221402 | Dentsply Sirona |
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| Technological characteristics / Performance / Composition / Biocompatibility | ||
| Sirona Dental CAD/CAM System (inCoris ZI meso material) | K111421 | Dentsply Sirona |
| Material Composition / Biocompatibility Only | ||
| Cercon | K162888 | Dentsply Sirona |
| Reverse Engineering Compatibility Testing | ||
| Sirona Dental CAD/CAM System with inLab Software | K200191 | Dentsply Sirona |
| Sirona Dental CAD/CAM System with CEREC Chairside Software | K193408 | Dentsply Sirona |
| Sirona Dental CAD/CAM System | K181520 | Dentsply Sirona |
| Sirona Dental CAD/CAM System | K100152 | Dentsply Sirona |
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| Compatible Dental Implants | 510(k) | Company Name |
|---|---|---|
| PrimeTaper EV | K210610 | Dentsply Sirona |
| OmniTaper EV | K221094 | Dentsply Sirona |
| AstraTech OsseoSpeed TX | K053384 | Dentsply Sirona |
| Frialit/ XiVE | K013867 | Dentsply Sirona |
| AstraTech Implant EV | K120414 | Dentsply Sirona |
| Ankylos | K083805 | Dentsply Sirona |
| Internal Connection | K143022,K071638,K093321,K042429 | BioHorizons |
| Replace, Replace Select | K020646 | Nobel Biocare |
| Nobel Active and NobelReplace Conical Connection | K071370 | Nobel Biocare |
| Branemark and NobelSpeedy Groovy | K022562 | Nobel Biocare |
| Straumann Tissue Level and Bone Level | K151324 | Straumann |
| Element, Contact | K093615,K090154 | Thommen Medical |
| Osstem TS (Hiossen ET) | K121585 | Osstem/Hiossen |
| External Hex, Certain and Tapered Screw-Vent | K061410,K061629,K014235 | Zimmer/Biomet |
| C1 Conical Connection, V3 Conical Connection,SEVEN internal hex and M4 internal hex | K191152 | Dentsply Sirona |
| Camlog | K083496 | Altatec 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 .
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-
- 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.
- Indications for Use:
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 .
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Compatible TiBase and Implant Systems
| Implant System | Titanium Base | |||
|---|---|---|---|---|
| Manufacturer / line | Platform | Name | REF | Size |
| Dentsply Sirona Implants | S | TiBase AT EV 3.6 GH 1 S | 6586312 | S |
| Primetaper EV | M | TiBase AT EV 4.2 GH 1 L | 6586320 | L |
| L | TiBase AT EV 4.8 GH 1 L | 6586338 | L | |
| 3.5 / 4.0 | TiBase AT TX 3.5/4.0 GH 1 L | 6598093 | L | |
| AstraTechOsseoSpeed TX | 4.5 / 5.0 | TiBase AT TX 4.5/5.0 GH 1 L | 6598101 | L |
| 3.5 / 4.0 | TiBase AT OS 3.5/4.0 GH 1 L | 6282532 | L | |
| 4.5 / 5.0 | TiBase AT OS 4.5/5.0 GH 1 L | 6282540 | L | |
| Frialit / Xive | 3.4 | TiBase FX 3.4 GH 1 S | 6282433 | S |
| 3.8 | TiBase FX 3.8 GH 1 S | 6282441 | S | |
| 4.5 | TiBase FX 4.5 GH 1 L | 6282458 | L | |
| 5.5 | TiBase FX 5.5 GH 1 L | 6282466 | L | |
| AstraTech ImplantEV | XL | TiBase AT EV 5.4 GH 1 L | 6586346 | L |
| Ankylos | C/X | TiBase ANK C/ GH 1 S | 6586528 | S |
| TiBase ANK C/ GH 2 S | 6586536 | S | ||
| TiBase ANK /X GH 1 S | 6586544 | S | ||
| TiBase ANK /X GH 2 S | 6586551 | S | ||
| BioHorizons | ||||
| Internal connection | 3.0 | TiBase BH 3.0 GH 1 S | 6532779 | S |
| 3.5 | TiBase BH 3.5 GH 1 L | 6532894 | L | |
| 4.5 | TiBase BH 4.5 GH 1 L | 6532951 | L | |
| 5.7 | TiBase BH 5.7 GH 1 L | 6536242 | L | |
| Nobel Biocare | ||||
| Replace, ReplaceSelect | NP | TiBase NB RS 3.5 GH 1 L | 6282474 | L |
| RP | TiBase NB RS 4.3 GH 1 L | 6282482 | L | |
| WP | TiBase NB RS 5.0 GH 1 L | 6282490 | L | |
| 6.0 | TiBase NB RS 6.0 GH 1 L | 6282508 | L | |
| Nobel Active | NP | TiBase NB A 4.5 GH 1 L | 6308188 | L |
| NobelReplaceConical Connection | RP | TiBase NB A 5.0 GH 1 L | 6308253 | L |
| Brånemark | NP | TiBase NB B 3.4 GH 1 L | 6282516 | L |
| NobelSpeedyGroovy | RP | TiBase NB B 4.1 GH 1 L | 6282524 | L |
| Straumann | ||||
| Tissue Level | RN (4.8 mm) | TiBase SSO 4.8 GH 1 L | 6284249 | L |
| WN (6.5 mm) | TiBase SSO 6.5 GH 1 L | 6284256 | L | |
| Bone Level | NC (3.3 mm) | TiBase S BL 3.3 GH 1 L | 6308154 | L |
| RC (4.1 mm / 4.8 mm) | TiBase S BL 4.1 GH 1 L | 6308337 | L | |
| Thommen Medical | ||||
| Element, Contact | 3.5 | TiBase TM 3.5 GH 1 S | 6531854 | S |
| 4 | TiBase TM 4 GH 1 S | 6532829 | S | |
| 4.5 | TiBase TM 4.5 GH 1 S | 6532837 | S | |
| 5 | TiBase TM 5 GH 1 S | 6544360 | S | |
| 6 | TiBase TM 6 GH 1 S | 6544378 | S | |
| Implant System | Titanium Base | |||
| Manufacturer / line | Platform | Name | REF | Size |
| Osstem / Hiossen | ||||
| Osstem TS | Mini | TiBase O TS 3.5 GH 1 L | 6527035 | L |
| (USA: Hiossen ET) | Regular | TiBase O TS 4.0 GH 1 L | 6527043 | L |
| Zimmer /Biomet | ||||
| 3.4 | TiBase B O 3.4 GH 1 L | 6282557 | L | |
| External hex | 4.1 | TiBase B O 4.1 GH 1 L | 6282565 | L |
| 5.0 | TiBase B O 5.0 GH 1 L | 6282573 | L | |
| 3.4 | TiBase B C 3.4 GH 1 S | 6308048 | S | |
| Certain | 4.1 | TiBase B C 4.1 GH 1 L | 6308097 | L |
| 5.0 | TiBase B C 5.0 GH 1 L | 6308121 | L | |
| 3.5 | TiBase Z TSV 3.5 GH 1 L | 6282581 | L | |
| Tapered Screw-Vent | 4.5 | TiBase Z TSV 4.5 GH 1 L | 6282599 | L |
| 5.7 | TiBase Z TSV 5.7 GH 1 L | 6282607 | L | |
| M.I.S | ||||
| C1 Conical | NP | CN-TB001 C1 NP GH 0.5 | CN-TB001 | L |
| Connection | CN-TB015 C1 NP GH 1.5 | CN-TB015 | L | |
| V3 Conical | VN-TB001 V3 NP GH 0.5 | VN-TB001 | L | |
| Connection | NP | VN-TB015 V3 NP GH 1.5 | VN-TB015 | L |
| V3 Conical | CS-TB001 SP GH 0.5 | CS-TB001 | L | |
| Connection, C1 | SP | CS-TB015 SP GH 1.5 | CS-TB015 | L |
| Conical Connection | CS-TB030 SP GH 3 | CS-TB030 | L | |
| CW-TB001 C1 WP GH 0.5 | CW-TB001 | L | ||
| C1 ConicalConnection | WP | CW-TB015 C1 WP GH 1.5 | CW-TB015 | L |
| CW-TB030 C1 WP GH 3 | CW-TB030 | L | ||
| MN-TB001 INT HEX NP GH 0.5 | MN-TB001 | L | ||
| NP | MN-TBC15 INT HEX NP GH 1.5 | MN-TBC15 | L | |
| MD-TB001 INT HEX SP GH 0.5 | MD-TB001 | L | ||
| SEVEN internal hex,M4 internal hex | SP | 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 | ||
| Straumann | ||||
| NNC (3.5 mm) | NNC Variobase C 3.5 GH 1 | 220.018 | S | |
| Tissue Level | RN (4.8 mm) | RN Variobase C GH 1 | 220.019 | L |
| WN (6.5 mm) | WN Variobase C GH 1 | 220.020 | L | |
| Bone Level | NC (3.3 mm) | NC Variobase C 3.3 GH 1 | 220.043 | S |
| RC (4.1 mm / 4.8 mm) | RC Variobase C 4.1 GH 1 | 220.044 | L | |
| Camlog | ||||
| 3.3 | CAMLOG® Titanium base CAD/CAM, for Ø 3.3 mm GH0.4 | K2244.3348 | S | |
| Camlog | 3.8 | CAMLOG® Titanium base CAD/CAM ,for Ø 3.8 mm GH0.3 | K2244.3848 | S |
| 4.3 | CAMLOG® Titanium base CAD/CAM, for Ø 4.3 mm GH0.3 | K2244.4348 | S | |
| 5.0 | CAMLOG® Titanium base CAD/CAM, for Ø 5.0 mm GH0.3 | K2244.5048 | L | |
| 6.0 | CAMLOG® Titanium base CAD/CAM, for Ø 6.0 mm GH0.3 | K2244.6048 | L |
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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™ AbutmentBlocks, CEREC Cercon 4DTMAbutment System (K234018) | Predicate DeviceCEREC Tessera Abutment Block,CEREC Tessera Abutment System(K221402) | Reference DeviceSirona Dental CAD/CAM System(inCoris ZI meso material)(K111421) | Discussion | |
| CEREC Cercon 4D™ AbutmentBlocks are a ceramic intended forfixed dental prosthetic restorations. | CEREC Tessera Abutment Blocks are aceramic intended for fixed dentalprosthetic restorations. | inCoris ZI meso blocks are intended for usein manufacturing individually designedmesostructures, which are glued to a fittingtitanium base after milling and sintering. | The proposed and predicatedevice have the same IntendedUse.The Intended Use of thereference device is similar toIntended Use of the proposedand predicate devices in that themesostructure is cemented to thetitanium base as part of a two-piece hybrid abutment. | |
| Table 6.2 - Comparison of Indications for Use | ||||
| CEREC Cercon 4D™ AbutmentBlocks, CEREC Cercon 4DTMAbutment System (K234018) | Predicate DeviceCEREC Tessera Abutment Block,CEREC Tessera Abutment System(K221402) | Reference DeviceSirona Dental CAD/CAM System(inCoris ZI meso material)(K111421) | Discussion | |
| CEREC Cercon 4D™ AbutmentSystem is intended for use inpartially or fully edentulousmandibles and maxillae in supportof single cement-retainedrestorations.The system comprises three parts:• CEREC Cercon 4D™ AbutmentBlock• TiBases• CAD/CAM system | CEREC Tessera Abutment System isintended for use in partially or fullyedentulous mandibles and maxillae insupport of single cement-retainedrestorations.The system comprises three parts:- CEREC Tessera Abutment Block- TiBase- CAD/CAM system | The Sirona Dental CAD/CAM System isintended for use in partially or fullyedentulous mandibles and maxillae insupport of single or multiple-unit cementretained restorations. The system consists ofthree major parts: TiBase, InCorismesostructure, and CAD/CAM software. | Same as predicate andreference devices.The reference device isadditionally indicated formultiple-unit cementretained restorations whichpertains to other materialsused within the CAD/CAMsystem. | |
| The CEREC Cercon 4D™ ceramicstructure cemented to the TiBase isrecommended for two-piece hybridabutments for single toothrestorations and hybrid abutmentcrowns, used in conjunction withendosseous dental implants. | The CEREC Tessera ceramic structurecemented to the TiBase is recommended fortwo-piece hybrid abutments for single toothrestorations and hybrid abutment crowns,used in conjunction with endosseous dentalimplants. | Specifically, the InCoris mesostructure andTiBase components make up a two-pieceabutment which is used in conjunction withendosseous dental implants to restore thefunction and aesthetics in the oral cavity. TheInCoris mesostructure may also be used inconjunction with the Camlog Titanium baseCAD/CAM (types K2244.xxxx) (K083496)in the Camlog Implant System. TheCAD/CAM software is intended to designand fabricate the InCoris mesostructure. | The proposed and predicatedevices are the same.The reference device issimilar with an additionaluse with Camlog ImplantSystem and Titanium base.The proposed block is alsoindicated for use with theCamlog (3rd party products).Fatigue testing to support theuse with 3rd party implantsystems and TiBases isincluded in the PerformanceBench Testing section. | |
| Table 6.2 - Comparison of Indications for Use | ||||
| CEREC Cercon 4D™ AbutmentBlocks, CEREC Cercon 4D™Abutment System (K234018) | Predicate DeviceCEREC Tessera Abutment Block,CEREC Tessera Abutment System(K221402) | Reference DeviceSirona Dental CAD/CAM System(inCoris ZI meso material)(K111421) | Discussion | |
| Implant Systems:• Dentsply Sirona: PrimeTaper EV,OmniTaper EV, AstraTechOsseoSpeed TX, Frialit / XiVE,AstraTech Implant EV, Ankylos• BioHorizons: Internal connection• Nobel Biocare: Replace, ReplaceSelect, Nobel Active,NobelReplace ConicalConnection , Brånemark,NobelSpeedy Groovy• Straumann: Tissue Level, BoneLevel• Thommen Medical: Element,Contact• Osstem/Hiossen: Osstem TS, USA:Hiossen ET• Zimmer/Biomet: External hex,Certain, Tapered Screw-Vent• MIS: C1 ConicalConnection, V3 ConicalConnection, SEVEN | The compatible Implant systems, titaniumbases and CAD/CAM systems are shownbelow:Implant Systems:• Dentsply Sirona: AstraTech OsseoSpeedTX (K053384), XiVE (K013867),AstraTech Implant EV (K120414),Ankylos (K083805), PrimeTaper EV(K210610)• MIS: C1 Conical connection (K172505NP, 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 thecompatible Titanium Bases | The InCoris mesostructure and TiBase two-piece abutment is compatible with thefollowing 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 notinclude implant system ortitanium bases in theIndications for Usestatement. Instead, acompatibility table for theImplant Systems andTiBases is included withinthe Instructions for Use(IFU). | |
| Table 6.2 - Comparison of Indications for Use | ||||
| CEREC Cercon 4D™ AbutmentBlocks, CEREC Cercon 4D™Abutment System (K234018) | Predicate DeviceCEREC Tessera Abutment Block,CEREC Tessera Abutment System(K221402) | Reference DeviceSirona 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 |
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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 predicatedevice CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and reference device inCoris ZI meso (K111421) | ||||
|---|---|---|---|---|
| Item ofComparison | Proposed DeviceCEREC Cercon 4D™Abutment Blocks, CERECCercon 4D™ AbutmentSystem (K234018) | Predicate DeviceCEREC Tessera AbutmentBlock, CEREC TesseraAbutment System(K221402) | Reference DeviceSirona Dental CAD/CAMSystem(inCoris ZI mesomaterial)(K111421) | Similarities and Differences |
| Product Code | Primary: NHASecondary: PNP | Primary: NHASecondary: PNP | NHA | Same to the predicate deviceand similar to the referencedevice |
| Manufacturer | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | Same |
| Abutment Angle | 0° to 20° | 0° to 20° | 0° to 20° | Same |
| Restoration | Single Unit | Single Unit | Single Unit | Same |
| Material | Zirconia1 | Advanced Lithium Disilicate | Zirconia1 | The proposed and referencedevice are both zirconiamaterials. The predicate devicediffers in material. |
| Cement(Adhesive/Glue) | Calibra AbutmentCement | Calibra Cement | No specific cementreferenced | Similar, the role of the cement isto glue the crown or meso-structure to the TiBase |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| 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 Comparison | Proposed DeviceCEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018) | Predicate DeviceCEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) | Reference DeviceSirona Dental CAD/CAM System (inCoris ZI meso material) (K111421) | Similarities and Differences |
| Sterilization Method | Steam Sterilization (final, assembled prosthetic restoration) | Steam Sterilization (final, assembled prosthetic restoration) | Steam sterilization (final, assembled prosthetic restoration) | Same |
| Biocompatibility | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Same |
| Fatigue | Meets ISO 14801 requirements | Meets ISO 14801 requirements | Meets ISO 14801 requirements | Same |
| Flexural Strength | Meets ISO 6872:2015 (Amd 1. 2018) requirements | Meets ISO 6872:2015 (Amd 1. 2018) requirements | Meets ISO 6872:2015 (Amd 1. 2018) requirements | Same |
| Software Verification | Meets internal software integration requirements for the addition of the proposed device CEREC Cercon 4D Abutment Blocks | Meets internal software integration requirements for the addition of the CEREC Tessera Abutment Block | Meets internal software integration requirements for the addition of the inCoris ZI meso | Same. The proposed, predicate and reference devices have all been integrated into the compatible Sirona CAD/CAM System software (K193408, K200191). |
| Design | Image: CEREC Cercon 4D Abutment | Image: CEREC Tessera Abutment | Image: Sirona inCoris ZI meso | Same.The proposed, predicate and reference devices are all shaped like a block and have a screw access channel. |
| MRI Safety Labeling | MRI Conditional | MRI 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).
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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 Performed | Test method/Applicable Standards | AcceptanceCriteria | Results |
| Flexural Strength(3-point bending strength) | ISO 6872:2015 Amd 1. 2018Dentistry-Ceramic Materials | >1,100 MPa | Pass |
| Table 8.2- Performance Specifications-Fatigue Strength | ||
|---|---|---|
| Test Performed | Test method/ApplicableStandards | Results |
| Fatigue Testing after steam sterilization- MISNarrow Platform conical connection C1-10330with CN-TB015 TiBase | Pass | |
| Fatigue Testing after steam sterilization- MISStandard Platform conical connection C1-08375with CS-TB030 TiBase | ISO 14801:2016 Dentistry-Implants-Dynamic loading | Pass |
| Fatigue Testing after steam sterilization- DSXiVE S Plus implant D3.4/L15 with DS TiBaseFX 3.4 S | test for endosseous dentalimplants | Pass |
| Fatigue Testing after steam sterilization- CamlogScrew-Line Implant nominal size 3.8mm length13.mm with Camlog Titanium Base CAD/CAM | Pass |
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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.
§ 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.)