(310 days)
CEREC 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 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.
The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The CEREC Tessera Abutment System is comprised of the proposed CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera ceramic structures are fabricated by milling the proposed CEREC Tessera Abutment Blocks. The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device.
The provided text describes a 510(k) premarket notification for the "CEREC Tessera Abutment Block, CEREC Tessera Abutment System." This is a dental device, not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to this document.
However, I can extract information regarding acceptance criteria and performance data for the dental device from the provided text.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Meets ISO 14801:2016 (Dynamic loading test for endosseous dental implants) | Meets ISO 14801 |
| Flexural Strength | ≥ 360 MPa (based on predicate device) | Average of 705 MPa |
| Material Properties | Meets ISO 6872:2015 Amd 1. 2018 (Dentistry - Ceramic Materials) | Meets criteria defined in ISO 6872 |
| Biocompatibility | Meets ISO 10993 requirements (specifically ISO 10993-1 and ISO 10993-5 for cytotoxicity) | Meets ISO 10993 requirements; confirmatory cytotoxicity test performed with satisfactory results |
| Cleaning/Disinfection | Validated per ISO 17664-1:2021, ANSI/AAMI ST79:2017, FDA Guidance (March 17, 2015), AAMI TIR-12:2010 | Manual and automated cleaning and automated disinfection processes validated |
| Sterilization | Achieves Sterility Assurance Level (SAL) of 10^-6 at 132° C for 4 minutes and 135° C for 3 minutes, meeting ANSI/AAMI ST79:2017, ISO 17665-1, ISO 17665-2 | Validated using a hybrid method; met specified SAL criteria |
| MRI Safety | Labeled as MRI Conditional | The subject device is labeled MRI Conditional (test data leveraged from K221094) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of number of test samples for each specific test, but the tests were performed "on the proposed CEREC Tessera Abutment System" and "on the proposed CEREC Tessera Abutment Block."
- Data Provenance: The studies are described as "Non-clinical bench testing" and "Biocompatibility evaluation assessment." The text does not specify the country of origin of the raw data, nor whether it's retrospective or prospective, as these terms are more typically applied to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a medical device clearance based on non-clinical bench testing.
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 a medical device clearance based on non-clinical bench testing, not an AI/ML diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (mechanical strength, flexural strength, material properties, biocompatibility, cleaning/sterilization processes), the "ground truth" is defined by adherence to established international standards (ISO, ANSI/AAMI), FDA guidance documents, and internal engineering requirements. This is essentially a bench test standard compliance type of ground truth.
8. The sample size for the training set
- Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML device requiring a training set.
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Dentsply Sirona Inc. Courtney Clark Senior Director of Regulatory Affairs, Corporate 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K221402
Trade/Device Name: CEREC Tessera Abutment Block, CEREC Tessera Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: February 21, 2023 Received: February 21, 2023
Dear Courtney Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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)
Device Name
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
Indications for Use (Describe)
CEREC 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 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.
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:
{3}------------------------------------------------
Titanium Bases:
| Implant system | |||||
|---|---|---|---|---|---|
| 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 | |
| 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 | 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 | |
| Prime Taper EV | M | TiBase AT EV 4.2 GH1 L | 6586320 | L | |
| L | TiBase AT EV 4.8 GH1 L | 6586338 | L | ||
| AstraTech Implant EV | XL | TiBase AT EV 5.4 GH1 L | 6586346 | L | |
| Ankylos | C/X | TiBase ANK C/ GH1 S | 6586528 | S | |
| 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 | |
| CN-TB015 C1 NP GH 1.5 | CN-TB015 | L | |||
| V3 Conical Connection | NP | VN-TB001 V3 NP GH 0.5 | VN-TB001 | L | |
| VN-TB015 V3 NP GH 1.5 | VN-TB015 | L | |||
| V3 Conical Connection,C1 Conical Connection | SP | CS-TB001 SP GH 0.5 | CS-TB001 | L | |
| CS-TB015 SP GH 1.5 | CS-TB015 | L | |||
| CS-TB030 SP GH 3 | CS-TB030 | L | |||
| C1 Conical Connection | WP | CW-TB001 C1 WP GH 0.5 | CW-TB001 | L | |
| CW-TB015 C1 WP GH 1.5 | CW-TB015 | L | |||
| CW-TB030 C1 WP GH 3 | CW-TB030 | L | |||
| SEVEN internal hex,M4 internal hex | NP | MN-TB001 INT HEX NP GH 0.5 | MN-TB001 | L | |
| 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 GH1.5 | MW-TBC15 | L | |||
| MW-TBC30 INT HEX WP GH 3 | MW-TBC30 | L |
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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/5/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a sans-serif font and is a similar color to the leaf-like shape.
510(k) SUMMARY
for
CEREC Tessera Abutment System (K221402)
-
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W
York, PA 17404
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W
Contact Person: Rebecca Sporer Telephone Number: 717-849-4793 Fax number: 717-849-4343
Date Prepared: March 22, 2023
-
- Device Name:
- Proprietary Name: CEREC Tessera Abutment Block, CEREC Tessera Abutment System
- Classification Name: ● Endosseous dental implant abutment
II
- CFR Number: 21 CFR 872.3630 ●
- Device Class: ●
- Product Code: NHA - Abutment, Implant, Dental Endosseous, ● PNP - Dental Abutment Design Software for Dental Laboratory
3. Predicate and Reference Devices:
The predicate and reference devices are noted below:
Predicate Device:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| IPS e.max® CAD Abutment Solutionextra systems | K191382 | Ivoclar Vivadent AG |
Reference Devices:
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| CELTRA Press | K161269 | Dentsply Sirona |
| Sirona Dental CAD/CAMSystems | K193408,K200191 | Dentsply Sirona |
{6}------------------------------------------------
4. Description of Device:
The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained The CEREC Tessera Abutment System is comprised of the proposed CEREC Tessera restorations. Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera ceramic structures are fabricated by milling the proposed CEREC Tessera Abutment Blocks. The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device.
5. Indications for Use:
CEREC 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 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.
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: Cl 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)
{7}------------------------------------------------
Titanium Bases:
| 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 |
| 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 | 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 |
| Prime Taper EV | M | TiBase AT EV 4.2 GH1 L | 6586320 | L |
| L | TiBase AT EV 4.8 GH1 L | 6586338 | L | |
| AstraTech Implant EV | XL | TiBase AT EV 5.4 GH1 L | 6586346 | L |
| Ankylos | 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 |
| CN-TB015 C1 NP GH 1.5 | CN-TB015 | L | ||
| V3 Conical Connection | NP | VN-TB001 V3 NP GH 0.5 | VN-TB001 | L |
| VN-TB015 V3 NP GH 1.5 | VN-TB015 | L | ||
| V3 Conical Connection,C1 Conical Connection | SP | CS-TB001 SP GH 0.5 | CS-TB001 | L |
| CS-TB015 SP GH 1.5 | CS-TB015 | L | ||
| CS-TB030 SP GH 3 | CS-TB030 | L | ||
| C1 Conical Connection | WP | CW-TB001 C1 WP GH 0.5 | CW-TB001 | L |
| CW-TB015 C1 WP GH 1.5 | CW-TB015 | L | ||
| CW-TB030 C1 WP GH 3 | CW-TB030 | L | ||
| SEVEN internal hex,M4 internal hex | NP | MN-TB001 INT HEX NP GH0.5 | MN-TB001 | L |
| MN-TBC15 INT HEX NP GH1.5 | MN-TBC15 | L | ||
| SP | MD-TB001 INT HEX SP GH0.5 | MD-TB001 | L | |
| MD-TBC15 INT HEX SP GH1.5 | MD-TBC15 | L | ||
| MD-TBC30 INT HEX SP GH 3 | MD-TBC30 | L | ||
| WP | MW-TB001 INT HEX WP GH0.5 | MW-TB001 | L | |
| MW-TBC15 INT HEX WP GH1.5 | MW-TBC15 | L | ||
| MW-TBC30 INT HEX WP GH3 | MW-TBC30 | L |
{8}------------------------------------------------
6. Substantial Equivalence:
For the purpose of substantial equivalence, the proposed CEREC Tessera Abutment System is compared to the legally marketed predicate device IPS e.max® CAD Abutment Solutions- extra systems marketed by Ivoclar Vivadent AG cleared under premarket notification K191382 on August 26, 2019. The proposed and predicate device (K191382) share the same intended use, similar indications for use, and product code information. Table 6.1 includes a comparison of the proposed and predicate devices.
The proposed CEREC Tessera Abutment System is compatible with additional implants system when compared to the predicate device, IPS e.max CAD Abutment Solution-extra systems (K191382). Table 6.1 compares the proposed compatible implant systems with those for the predicate device. The proposed compatible implant systems are based on the marketing strategy for the proposed CEREC Tessera Abutment Block. Dentsply Sirona owns the engineering drawing and fatigue data of all compatible implant systems and also have clearance for these implant systems under the Sirona Dental CAD/CAM System (K193408, K200191).
Additionally, Dentsply Sirona's CELTRA Press (K161269) and Sirona Dental CAD/CAM Systems (K193408, K200191) are being included as a reference device for comparison of material composition and characteristics to support the substantial equivalence of the proposed CEREC Tessera Abutment Blocks as well compatibility with the Sirona Dental CAD/CAM systems. Table 6.2 includes a comparison of the proposed and reference devices.
{9}------------------------------------------------
| Table 6.1: Comparison table between the proposed CEREC Tessera Abutment System and IPS e.max® CAD Abutment Solutions-extra systems (K191382) | |||
|---|---|---|---|
| Characteristics | Proposed CEREC TesseraAbutment System | IPS e.max® CAD AbutmentSolutions- extra systemsPredicate Device(K191382) | Similarities and Differences |
| Indications forUse | CEREC Tessera Abutment Systemis intended for use in partially orfully edentulous mandibles andmaxillae in support of singlecement-retained restorations. | IPS e.max CAD Abutment Solutionsis intended for use in partially or fullyedentulous mandibles and maxillae insupport of single cement-retainedrestorations. | Same intended use. |
| Indications forUse | The system comprises three parts:- CEREC Tessera Abutment Block- TiBase- CAD/CAM system. | The system comprises three parts:- IPS e.max CAD ceramic structure- Ti base- CAD/CAM system. | Similar, minor difference in wording.The predicate device describes theceramic component as a "ceramicstructure" whereas the proposeddevice is described as a block,"CEREC Tessera Abutment Block".The proposed device is described as ablock, which is utilized to mill a singleunit restoration, which is known as aceramic structure. |
| Indications forUse | The CEREC Tessera ceramicstructure cemented to the TiBase isrecommended for two-piece hybridabutments for single toothrestorations and hybrid abutmentcrowns, used in conjunction withendosseous dental implants. | The IPS e.max CAD ceramicstructure cemented to the Ti base isrecommended for two-piece hybridabutments for single toothrestorations and hybrid abutmentcrowns, used in conjunction withendosseous dental implants. | Same |
{10}------------------------------------------------
| Table 6.1: Comparison table between the proposed CEREC Tessera Abutment System and IPS e.max® CAD Abutment Solutions- extra systems (K191382) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristics | Proposed CEREC Tessera Abutment System | IPS e.max® CAD Abutment Solutions- extra systems Predicate Device (K191382) | Similarities and Differences | ||||||||||||||||||||||||
| Compatible Materials | 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) | The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:-Implant Systems:- Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)- BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429)- Osstem: TS Implant System (K121585)- Straumann: Tissue Level RN/WN (K061176)- Nobel Biocare: Branemark (K022562)- Zimmer: Tapered Screw-Vent (K061410)- Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991) | -The proposed CEREC Tessera Abutment System and the predicate device IPS e.max® CAD Abutment Solutions- extra systems (K191382) are intended for use with compatible TiBase and implant systems. Similarities and differences are described below :Name Proposed Device Predicate Device AstraTech OsseoSpeed Compatible with AstraTech OsseoSpeed TX Compatible with AstraTech OsseoSpeed XiVE Compatible Compatible Frialit Not listed Compatible AstraTech Implant EV / PrimeTaper EV Compatible Not listed Ankylos Compatible Not listed MIS C1, V3, SEVEN, M4 Compatible Not listed BioHorizons, Osstem, Straumann, Nobel Biocare: Branemark, Zimmer, Camlog Not listed Compatible |
{11}------------------------------------------------
| Table 6.1: Comparison table between the proposed CEREC Tessera Abutment System and IPS e.max® CAD Abutment Solutions- extra systems (K191382) | |||
|---|---|---|---|
| Characteristics | Proposed CEREC TesseraAbutment System | IPS e.max® CAD AbutmentSolutions- extra systemsPredicate Device(K191382) | Similarities and Differences |
| CAD/CAMSystems | CAD/CAM Systems:-Sirona Dental CAD/CAM System(CEREC-K193408, inLab-K200191) | CAD/CAM Systems: Sirona DentalCAD/CAM System (K181520) | -Both the proposed CEREC TesseraAbutment and the predicate deviceIPS e.max® CAD AbutmentSolutions- extra systems (K191382)are indicated for use with the SironaDental CAD/CAM System withCEREC chairside software (Pre-market clearance K193408 representsan update to Dentsply SironaCAD/CAM system cleared underK181520).-The proposed CEREC TesseraAbutment system can also be usedwith Inlab software (K200191). |
| Product Code | NHA, PNP | NHA, PNP | Same |
| Manufacturer | Dentsply Sirona | Ivoclar Vivadent, AG | Different manufacturer |
| Abutment Angle | 0° to 20° | 0° to 20° | Same |
| Restoration | Single Unit | Single Unit | Same |
| Block Material | Lithium Disilicate | Lithium Disilicate | Same |
| Characteristics | Proposed CEREC TesseraAbutment System | IPS e.max® CAD AbutmentSolutions- extra systemsPredicate Device(K191382) | Similarities and Differences |
| Cement(Adhesive) | Calibra Cement | Multilink Hybrid Abutment | The proposed device is recommendedfor use with Calibra Cement while thepredicate device recommendsMultilink Hybrid Abutment cement.The role of the cement is to glue thecrown or meso-structure to theTiBase. |
| Sterility | Non-Sterile | Non-Sterile | Same |
| SterilizationMethod | Steam Sterilization | Steam Sterilization | Same |
| FlexuralStrength(ISO 6872) | Average of 705 MPa | ≥ 360 MPa (K132209) | The proposed device has higherflexural strength than the predicatedevice. |
| Biocompatibility | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Both the proposed and predicatedevices meet the criteria of ISO 10993 |
| Fatigue | Meets ISO 14801 | Meets ISO 14801 | Both the proposed and predicatedevices have comparable propertiesper ISO 14801 |
| Software | Meets internal software integrationrequirements for addition theproposed device CEREC TesseraAbutment Block | Information unavailable for thepredicate devices | The proposed CEREC TesseraAbutment Block has been integratedinto Sirona CAD/CAM Systemsoftware (K193408, K200191). |
| Characteristics | Proposed CEREC TesseraAbutment System | IPS e.max® CAD AbutmentSolutions- extra systemsPredicate Device(K191382) | Similarities and Differences |
| MRI SafetyLabeling | The subject device is labeled MRIConditional | Unavailable | MRI test data leveraged from K221094 |
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Table 6.1: Comparison table between the proposed CEREC Tessera Abutment System and IPS e.max® CAD Abutment Solutionsextra systems (K191382)
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Table 6.1: Comparison table between the proposed CEREC Tessers Abutment System and IPS e.max® CAD Abutment Solutionsextra systems (K191382)
Although the proposed and the predicate IPS e.max® CAD Abutment Solutions- extra systems (K191382) are composed of Lithium Disilicate glass ceramic structure material, the exact formulation of the predicate ceramic structure material (K191382) is not available. Therefore, reference device CELTRA Press (K161269) is included to support the technological material characteristics of the proposed CEREC Tessera Abutment Block.
The proposed CEREC Tessera Abutment Block is identical in formulation to the reference device CELTRA Press (K161269). The material of the proposed device and the reference device (K161269) meets the performants of ISO 6872:2015 (Amd 1. 2018), Dentistry – Ceramic Materials and FDA Guidance Use of International Standard ISO 1099-1, "Biological evaluation of nedical devices - Part 1: Evaluation and testing within a risk management process".
| Table 6.2: Comparison of technological characteristics of the proposed CEREC Tessera Abutment Block with reference device |
|---|
| CELTRA Press (K161269) |
| Characteristics | Proposed CEREC TesseraAbutment Block | Reference CELTRA Press(K161269) | Similarities and Differences |
|---|---|---|---|
| Formulation | Lithium disilicate | Lithium disilicate | Same |
| ISO 6872:2015 Amd 1. 2018 | Meets criteria defined in ISO6872 | Meets criteria defined in ISO6872 | Same, meets criteria defined inISO 6872 |
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7. Non-Clinical Performance Data
Performance testing:
Non-clinical bench testing was performed on the proposed CEREC Tessera Abutment System in accordance with ISO 14801:2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants and on the proposed CEREC Tessera Abutment Block per ISO 6872:2015 Amd 1. 2018 Dentistry - Ceramic Materials.
Biocompatibility Testing:
Biocompatibility evaluation assessment for the proposed device CEREC Tessera Abutment Block was performed according to ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The proposed CEREC Tessera Abutment Block has the same composition, patient contact point and duration of use as the reference device, CELTRA Press (K161269), which was assessed and tested for biological safety, and does not raise additional questions of safety or effectiveness. A confirmatory cytotoxicity test per 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity was performed with satisfactory results.
The performance of the proposed CEREC Tessera Abutment Block satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Cleaning, Disinfection, and Sterilization Testing CEREC Tessera Abutment System:
The manual and automated cleaning process and the automated disinfection processes were validated according to
- . ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the Processing of medical devices, and
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterilitv . assurance in health care facilities
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff Document issued on: March 17, 2015
- AAMI TIR-12:2010 Designing, testing, and labeling reusable medical devices for . reprocessing in health care facilities: A guide for medical device manufacturers
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In addition, the sterilization process was validated using a hybrid method to ensure that the proposed device can be steam sterilized at 132° C for 4 minutes and 135° C for 3 minutes and achieve a Sterility Assurance Level (SAL) of 106. In addition to the above standards and guidance documents, sterilization test results also met the criteria of ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 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, and ISO 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
8. Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of the proposed CEREC Tessera Abutment Blocks or CEREC Tessera Abutment System.
9. Conclusion Regarding Substantial Equivalence
The proposed CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The proposed device CEREC Tessera Abutment System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate IPS e.max® CAD Abutment Solutions- extra systems (K191382). Test data to verify the performance of the proposed device was provided including dynamic fatigue testing and physical properties and the results of this testing, combined with the design and indications for use comparison with the predicate device, support 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.)