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

For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

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: Astra Tech OsseoSpeed TX, Ankylos
• BioHorizons: Internal connection
• Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Concial Connection, Branemark, 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
• MIS: C1 Conical connection (NP and WP), V3 Conical connection, SEVEN internal hex, M4 internal hex

CAD/CAM Systems:

• Sirona Dental CAD/CAM System

Titanium Bases:

Implant: AstraTech Osseospeed TX

• Platform: 3.5/4.0; TiBase AT TX 3.5/4.0 GH1 L; Reference 6598093; Size L
• Platform: 4.5/5.0; TiBase AT TX 4.5/5.0 GH1 L; Reference 6598101; Size L
• Platform: 3.5/4.0; TiBase AT OS 3.5/4.0 GH1 L; Reference 6282532; Size L
• Platform: 4.5/5.0; TiBase ATOS 4.5/5.0 GH1 L; Reference 6282540; Size L

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: M.I.S. Implants

Implant: C1 Conical Connection

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

Implant: V3 Conical Connection

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

Implant: V3 Conical Connection / C1 Conical Connection

• Platform: SP; CS-TB001 SP GH 0.5; Reference CS-TB001; Size: L
• Platform: SP; CS-TB015 SP GH 1.5; Reference CS-TB015; Size: L
• Platform: SP; CS-TB030 SP GH 3; Reference CS-TB030; Size: L

Implant: C1 Conical Connection

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

Implant: SEVEN internal hex, M4 internal hex

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

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, Nobel Replace Conical Connection

• Platform: NP; TiBase NB A 4.5 GH 1 L; Reference 6308188; Size: L
• Platform: RP; TiBase NB A 5.0 GH 1 L; Reference 6308253; Size: L

Implant: Branemark

• 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
• 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 BO 3.4 GH 1 L; Reference 6282557; Size: L
• Platform: 4.1; TiBase BO 4.1 GH 1 L; Reference 6282565; Size: L
• Platform: 5.0; TiBase BO 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 BC 4.1 GH 1 L; Reference 6308097; Size: L
• Platform: 5.0; TiBase BC 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: Straumann

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 CAD/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

The proposed CEREC Tessera Abutment System is a modification of the previously cleared CEREC Tessera Abutment Block (K221402). The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The proposed CEREC Tessera Abutment System (with the additional TiBase and Implant System compatibilities and change in wall thickness) is comprised of the 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 Abutment Blocks are not provided as the finished, fully assembled dental implant medical device. The CEREC Tessera 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.

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 following patient-specific ranges for CAD/CAM fabrication of the abutments are:

• Maximum angulation of 20°
• Minimal wall thickness of 0.5 mm
• Gingival height ranges from 0.5 mm -3.0 mm
• Minimum abutment post height (i.e. length above the gingival height) of >4 mm

N/A

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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

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.

Ask a specific question about this device

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

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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