(251 days)
No
The document describes a CAD/CAM system for designing and fabricating dental abutments, focusing on hardware components, software for design and fabrication, and compatibility with implant systems. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is a CAD/CAM system intended for the design and fabrication of two-piece dental abutments, which are components used in conjunction with endosseous dental implants to restore function and aesthetics. While the abutments serve a therapeutic purpose, the described device itself is a manufacturing system rather than a device directly applied to a patient for therapeutic effect.
No
The device is intended for the design and fabrication of two-piece, CAD/CAM dental abutments, which is a manufacturing process, not a diagnostic one. While it acquires topographical characteristics, this is for design purposes, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components as part of the system, including digital acquisition units, an intraoral scanner, milling units, and physical titanium base components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for designing and fabricating dental restorations (two-piece abutments) used in conjunction with dental implants to restore function and aesthetics in the oral cavity. This is a mechanical/restorative function, not a diagnostic one.
- Device Description: The description details the components of the system, which are focused on digital scanning, CAD/CAM design, and milling of physical dental components. There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The Sirona Dental CAD/CAM System is a dental restorative system used for creating custom dental prosthetics.
N/A
Intended Use / Indications for Use
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and SBL 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 consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:
Nobel Biocare (Replace, Active, Branemark), Straumann (Synocta, Bone Level), Dentsply Sirona Implants (Osseospeed, Xive, Osseospeed EV, Ankylos, Osseospeed TX), Biomet 3i (Osseotite, Certain), Zimmer (Tapered Screw-Vent), Thommen Medical (Thommen Medical Implants), Osstem / Hiossen (Osstem TS Implant System, Hiossen Implant System), BioHorizons (Internal Connection) (Tapered 3.0, Tapered plus, Tapered internal, Tapered internal tissue level, Internal dental implant, Single stage dental implants).
Product codes
NHA, PNP
Device Description
The Sirona Dental CAD/CAM System with CEREC Chairside Software is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:
- CEREC SW "chairside" CAD/CAM software
- CEREC AC digital acquisition unit
- CEREC AC Connect digital acquisition unit
- CEREC Omnicam 3D digital intraoral scanner
- CEREC MCXL product family of CAM milling units
- Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
- inCoris ZI zirconium mesostructure blocks
As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.
As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.
The CEREC SW CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D digital intraoral scanner for digital acquisition of topographical characteristics of teeth, dental impressions, or physical stone models.
Anatomical Site
partially or fully edentulous mandibles and maxillae, oral cavity (for dental implants).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Geometric compatibility of implant to TiBase connection interface confirmed via direct access to original manufacturer's implant geometry specifications for Dentsply Sirona, OsseoSpeed TX implant system.
- Dynamic fatigue testing of new TiBase variants in worst-case construct according to ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants). Test design included test sample constructs fabricated at the maximum allowable abutment angulation and utilizing TiBase components exhibiting the worst-case design with respect to implant connection interface geometry.
- New TiBase variants are composed of identical materials and fabricated utilizing same methods as components cleared under K181520.
- Recommended steam sterilization parameters for new TiBase components are identical to validated parameters for TiBase components cleared under K181520. Validation conducted according to ISO 17665-1 and ANSI/AAMI ST79.
- Software system integration testing conducted to validate system requirements associated with the introduction of the TiBase component line extension as selectable within the CEREC Chairside CAD/CAM software for the design and fabrication of two-piece CAD/CAM dental abutments. No modification to the CEREC CAD/CAM abutment design software's controls limiting the critical abutment design parameters.
Clinical Performance Data:
No human clinical data was included in this premarket notification.
Key Results: The results of the performance testing support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2020
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401
Re: K193408
Trade/Device Name: Sirona Dental CAD/CAM System with CEREC Chairside Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: July 16, 2020 Received: July 17, 2020
Dear Karl Nittinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (OS) 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.
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Sirona Dental CAD/CAM System with CEREC Chairside Software
Indications for Use (Describe)
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cetained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and SBL 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 consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:
| Manufacturer | Name of Implant System | Implant Size | |
|---|---|---|---|
| Platform | Diameter | ||
| Nobel Biocare | Replace | NP | 3.5 |
| RP | 4.3 | ||
| WP | 5.0 | ||
| 6.0 | 6.0 | ||
| Nobel Biocare | Active | NP | 3.5 |
| RP | 4.3/5.0 | ||
| Branemark | NP | 3.3 | |
| RP | 3.75/4.0 | ||
| Straumann | Synocta | NN (3.5mm) | 3.3 |
| RN (4.8mm) | 3.3/4.1/4.8 | ||
| WN (6.5mm) | 4.8 | ||
| Bone Level | NC (3.3mm) | 3.3 | |
| RC (4.1mm/4.8mm | 4.1/4.8 | ||
| Dentsply Sirona Implants | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S |
| 4.5/5.0 | 4.5/5.0/5.0 S | ||
| Xive | 3.4 | 3.4 | |
| 3.8 | 3.8 | ||
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| Osseospeed EV | 3.6 | 3.6 | |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| Dentsply Sirona Implants | 5.4 | 5.4 | |
| Ankylos | C/X | A, B, C, D | |
| Osseospeed TX | 3.0 | 3.0 | |
| 3.5/4.0 | 3.5/4.0 | ||
| 4.5/5.0 | 4.5/5.0 | ||
| Osseotite | 3.4 | 3.25 | |
| 3.75 | |||
| 4.1 | 4.1 | ||
| 3/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Certain | 3.4 | 3.25 | |
| Biomet 3i | 4/3 | ||
| 3/4/3 | |||
| 4.1 | 4.0 | ||
| 4/5/4 | |||
| 5/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Tapered Screw-Vent | 3.5 | 3.7/4.1 | |
| Zimmer | 4.5 | 4.7 | |
| 5.7 | 6 | ||
| Thommen Medical Implants | 3.5 | 3.5 | |
| Thommen Medical | 4 | 4 | |
| 4.5 | 4.5 | ||
| 5 | 5 | ||
| 6 | 6 | ||
| Osstem TS Implant System | Mini | 3.5 | |
| Osstem / Hiossen | Hiossen Implant System | Regular | 4.0/4.5/5.0/6.0/7.0 |
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| Tapered 3.0,Tapered plus | 3.0 | 3.0/3.4/3.8 | |
| Tapered internal | 3.0 | 3.0 | |
| Tapered plus | 4.6 | ||
| Tapered internal, Tapered | |||
| internal tissue level | 3.5 | 3.0/3.8 | |
| Internal dental implant | 3.5 | ||
| Single stage dental implants | 3.5/4.0 | ||
| BioHorizons | |||
| (Internal Connection) | Tapered Plus | 5.8 | |
| Tapered internal, Tapered | |||
| internal tissue level | 4.5 | 4.6 | |
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| Tapered internal, Tapered | |||
| internal tissue level | 5.7 | 5.8 | |
| Internal dental implant, | |||
| Single stage dental implants | 5.0/6.0 |
3
4
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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5
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/5/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized, curved shape on the left, followed by the text "Dentsply" on the first line and "Sirona" on the second line. The text is in a simple, sans-serif font and is aligned to the right of the curved shape.
510(k) SUMMARY
for
Sirona Dental CAD/CAM System with CEREC Chairside Software (K193408)
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
| Email: | karl.nittinger@dentsplysirona.com |
11 August 2020 Date Prepared:
-
- Device Name:
| • | Proprietary Name: | Sirona Dental CAD/CAM System with
CEREC Chairside Software |
|---|-------------------------|----------------------------------------------------------------|
| • | Classification Name: | Endosseous dental implant abutment. |
| • | CFR Number: | 21 CFR 872.3630 |
| • | Device Class: | Class II |
| • | Primary Product Code: | NHA (Abutment, Implant, Dental Endosseous) |
| • | Secondary Product Code: | PNP (Dental Abutment Design Software for Dental
Laboratory) |
3. Predicate Device:
The predicate device that has been identified relating to the substantial equivalence of the Sirona Dental CAD/CAM System with CEREC Chairside Software is:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Sirona Dental CAD/CAM System | K181520 | Sirona Dental Systems GmbH |
| (Dentsply Sirona) | ||
| Reference Device Name | ||
| Osseospeed TX implant (3.5, 4.0, 4.5, 5.0) | K080156 | Astra Tech AB |
| (Dentsply Sirona) | ||
| Osseospeed TX Implant (3.0) | K080396 | Astra Tech AB |
| (Dentsply Sirona) |
6
4. Description of Device:
The Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:
- CEREC SW "chairside" CAD/CAM software
- CEREC AC digital acquisition unit
- CEREC AC Connect digital acquisition unit ●
- CEREC Omnicam 3D digital intraoral scanner ●
- CEREC MCXL product family of CAM milling units
- Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
- inCoris ZI zirconium mesostructure blocks ●
As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.
As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.
The CEREC SW CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.
7
5. Indications for Use:
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and SBL 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 consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two- piece abutment is compatible with the following implant systems:
| Manufacturer | Name of Implant System | Implant Size | |
|---|---|---|---|
| Platform | Diameter | ||
| Nobel Biocare | Replace | NP | 3.5 |
| RP | 4.3 | ||
| WP | 5.0 | ||
| 6.0 | 6.0 | ||
| Nobel Biocare | Active | NP | 3.5 |
| RP | 4.3/5.0 | ||
| Branemark | NP | 3.3 | |
| RP | 3.75/4.0 | ||
| Straumann | Synocta | NN (3.5mm) | 3.3 |
| RN (4.8mm) | 3.3/4.1/4.8 | ||
| WN (6.5mm) | 4.8 | ||
| Bone Level | NC (3.3mm) | 3.3 | |
| RC (4.1mm/4.8mm | 4.1/4.8 | ||
| Dentsply Sirona Implants | Osseospeed | 3.5/4.0 | 3.5 S / 4.0 S |
| 4.5/5.0 | 4.5/5.0/5.0 S | ||
| Xive | 3.4 | 3.4 | |
| 3.8 | 3.8 | ||
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| Dentsply Sirona Implants | Osseospeed EV | 3.6 | 3.6 |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| Ankylos | C/X | A, B, C, D | |
| 3.0 | 3.0 | ||
| Osseospeed TX | 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | ||
| Biomet 3i | Osseotite | 3.4 | 3.25 |
| 3.75 | |||
| 4.1 | 4.1 | ||
| 3/4 | |||
| 5.0 | 5.0 | ||
| 5.0 | |||
| Certain | 3.25 | ||
| 3.4 | 4/3 | ||
| 3/4/3 | |||
| 4.0 | |||
| 4.1 | 4/5/4 | ||
| 5/4 | |||
| 5.0 | 5.0 | ||
| 4/5 | |||
| Zimmer | Tapered Screw-Vent | 3.5 | 3.7/4.1 |
| 4.5 | 4.7 | ||
| 5.7 | 6 | ||
| Thommen Medical | Thommen Medical Implants | 3.5 | 3.5 |
| 4 | 4 | ||
| 4.5 | 4.5 | ||
| 5 | 5 | ||
| 6 | 6 | ||
| Osstem / Hiossen | Osstem TS Implant System | Mini | 3.5 |
| Hiossen Implant System | Regular | 4.0/4.5/5.0/6.0/7.0 | |
| Manufacturer | Name of Implant System | Implant Size | |
| Platform | Diameter | ||
| BioHorizons | |||
| (Internal Connection) | Tapered 3.0,Tapered plus | 3.0 | 3.0/3.4/3.8 |
| Tapered internal | 3.0 | ||
| Tapered plus | 4.6 | ||
| Tapered internal, Tapered | |||
| internal tissue level | 3.5 | 3.0/3.8 | |
| Internal dental implant | 3.5 | ||
| Single stage dental implants | 3.5/4.0 | ||
| BioHorizons | |||
| (Internal Connection) | Tapered Plus | 5.8 | |
| BioHorizons | |||
| (Internal Connection) | Tapered internal, Tapered | ||
| internal tissue level | 4.5 | 4.6 | |
| Internal dental implant | 4.0 | ||
| Single stage dental implants | 4.0/5.0 | ||
| BioHorizons | |||
| (Internal Connection) | Tapered internal, Tapered | ||
| internal tissue level | 5.8 | ||
| Internal dental implant, | |||
| Single stage dental implants | 5.7 | 5.0/6.0 |
8
9
6. Substantial Equivalence:
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software has the same intended use as the predicate Sirona Dental CAD/CAM System cleared under premarket notification K181520. Both the modified Sirona Dental CAD/CAM System with CEREC Chairside Software and the predicate device are intended as optical impression systems for the 3D digital acquisition of the topography of teeth for use in the design and manufacturing of two-piece "CAD/CAM" dental abutments. As such, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software and the predicate device cleared under premarket notification K181520 are regulated under 21 CFR 872.3630.
Osseospeed TX implant (K080156 and K080396) is listed as a reference device for the purpose of showing clearance of the additional implant system that the modified Sirona Dental CAD/CAM System with CEREC Chairside Software is compatible with. The previously cleared reference device, Osseospeed TX implant (K080156 and K080396) is not changed in any aspect (e.g. diameter) under the scope of this submission.
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification and the predicate cleared under premarket notification K181520 include the same scanning, acquisition, and milling equipment, and utilize the same TiBase and inCoris ZI zirconia mesostructure materials for the design and fabrication of two-piece, CAD/CAM dental abutments.
The primary differences between the modified Sirona Dental CAD/CAM System with CEREC Chairside Software and the predicate device cleared in K181520 is the line extension of the available variants of the existing Sirona TiBase titanium base component offerings to facilitate compatibility with an additional dental implant system (Osseospeed TX).
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Summary comparison of the intended use, indications for use, and design of the modified Sirona Dental CAD/CAM System with CEREC Chairside Software and the predicate, Sirona Dental CAD/CAM System (K181520), is presented in Tables 6.1 and 6.2.
Table 6.1: Indications for Use
| Modified Device | Predicate Device |
|---|---|
| Sirona Dental CAD/CAM System with | Sirona Dental CAD/CAM System |
| CEREC Chairside Software | (K181520) |
| The Sirona Dental CAD/CAM System with CEREC Chairside Software is | The Sirona Dental CAD/CAM System is intended for use in partially or |
| intended for use in partially or fully edentulous mandibles and maxillae in | fully edentulous mandibles and maxillae in support of single or multiple- |
| support of single or multiple-unit cement retained restorations. For the AT | unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL |
| TX 3.0 S, BH 3.0 S, SSO 3.5 L and SBL 3.3 L titanium bases, the indication | 3.3 L titanium bases, the indication is restricted to the replacement of |
| is restricted to the replacement of single lateral incisors in the maxilla and | single lateral incisors in the maxilla and lateral and central incisors in the |
| lateral and central incisors in the mandible. The system consists of three | mandible. The system consists of three major parts: TiBase, inCoris |
| major parts: TiBase, inCoris mesostructure, and CAD/CAM software. | mesostructure, and CAD/CAM software. Specifically, the inCoris |
| Specifically, the inCoris mesostructure and TiBase components make up a | mesostructure and TiBase components make up a two-piece abutment |
| two-piece abutment which is used in conjunction with endosseous dental | which is used in conjunction with endosseous dental implants to restore |
| implants to restore the function and aesthetics in the oral cavity. The inCoris | the function and aesthetics in the oral cavity. The inCoris mesostructures |
| mesostructure may also be used in conjunction with the Camlog Titanium | may also be used in conjunction with the Camlog Titanium base |
| base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant | CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant |
| System. The CAD/CAM software is intended to design and fabricate the | System. The CAD/CAM software is intended to design and fabricate the |
| inCoris mesostructure. The inCoris mesostructure and TiBase two-piece | inCoris mesostructure. The inCoris mesostructure and TiBase two-piece |
| abutment is compatible with the following implant systems: | abutment is compatible with the following implant systems: |
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| Manufacturer | Name of
Implant
System | Implant Sizes | |
|--------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------|
| | | Platform | Diameter |
| Nobel Biocare | Replace | NP
TP
WP
6.0 | 3.5
4.3
5.0
6.0 |
| Nobel Biocare | Active | NP
RP | 3.5
4.3/5.0 |
| Branemark | | NP
RP | 3.3
3.75/4.0 |
| Straumann | Synocta | NN (3.5mm)
RN (4.8mm)
WN (6.5mm)
NC (3.3mm) | 3.3
3.3/4.1/4.8
4.8
3.3 |
| Straumann | Bone Level | RC
(4.1mm/4.8mm) | 4.1/4.8 |
| | Osseospeed | 3.5/4.0
4.5/5.0 | 3.5 S / 4.0 S
4.5/5.0/5.0 S |
| | Xive | 3.4
3.8
4.5
5.5 | 3.4
3.8
4.5
5.5 |
| Dentsply
Sirona
Implants | Osseospeed
EV | 3.6
4.2
4.8
5.4 | 3.6
4.2
4.8
5.4 |
| | Ankylos | C/X | A, B, C, D |
| | Osseospeed
TX | 3.0
3.5/4.0
4.5/5.0 | 3.0
3.5/4.0
4.5/5.0 |
| | Osseotite | 3.4
4.1
5.0 | 3.25
3.75
4.1
3/4
5.0
4/5 |
| Biomet 3i | Certain | 3.4
4.1
5.0 | 3.25
4/3
3/4/3
4.0
4/5/4
5/4
5.0
4/5 |
| Zimmer | Tapered
Screw-Vent | 3.5
4.5
5.7 | 3.7/4.1
4.7
6 |
| Thommen
Medical | SPI
ELEMENT,
SPI
ELEMENT
INICELL,
SPI
CONTACT
INICELL | 4
4.5
5
6 | 4
4.5
5
6 |
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| | CONTACT
INICELL | | | | | Osstem TS
Implant | Mini | 3.5 |
|-----------------------------------------|----------------------------------------------------------------------|----------|--|---------------------------|-----------------------------------------|-------------------------------------------------------------|----------|---------------------------|
| Manufacturer | Name of
Implant
System | Platform | | Implant Sizes
Diameter | Osstem /
Hiossen | System-
Hiossen
Implant
System | Regular | 4.0/4.5/5.0/6.0/7.0 |
| | Osstem TS
Implant
System- | Mini | | 3.5 | Manufacturer | Name of
Implant | Platform | Implant Sizes
Diameter |
| Osstem /
Hiossen | Hiossen
Implant
System | Regular | | 4.0/4.5/5.0/6.0/7.0 | | System
Tapered
3.0,
Tapered | | 3.0/3.4/3.8 |
| | Tapered
3.0,
Tapered | | | 3.0/3.4/3.8 | | plus
Tapered
Internal | 3.0 | 3.0 |
| | plus
Tapered | 3.0 | | 3.0 | | Tapered
plus | | 4.6 |
| | Internal
Tapered
plus
Tapered
internal, | | | 4.6 | | Tapered
internal,
Tapered
internal
tissue level | 3.5 | 3.0/3.8 |
| | Tapered
internal
tissue level | 3.5 | | 3.0/3.8 | | Internal
dental
implant | | 3.5 |
| | Internal
dental
implant | | | 3.5 | | Single stage
dental
implants | | 3.5/4.0 |
| | Single stage
dental | | | 3.5/4.0 | BioHorizons
(Internal
Connection) | Tapered
plus | 4.5 | 5.8 |
| BioHorizons
(Internal
Connection) | implants
Tapered
plus
Tapered | 4.5 | | 5.8 | | Tapered
internal,
Tapered
internal | | 4.6 |
| | internal,
Tapered
internal
tissue level | | | 4.6 | | tissue level
Internal
dental
implant | | 4.0 |
| | Internal
dental
implant | | | 4.0 | | Single stage
dental
implants | | 4.0/5.0 |
| | Single stage
dental
implants
Tapered | | | 4.0/5.0 | | Tapered
internal,
Tapered
internal | 5.7 | 5.8 |
| | internal,
Tapered
internal
tissue level | 5.7 | | 5.8 | | tissue level
Internal
dental
implant, | | |
| | Internal
dental
implant,
Single stage
dental
implants | | | 5.0/6.0 | | Single stage
dental
implants | | 5.0/6.0 |
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Table 6.2: Design
| Modified Device
Sirona Dental CAD/CAM System with
CEREC Chairside Software | Predicate Device
Sirona Dental CAD/CAM System
(K181520) |
|----------------------------------------------------------------------------------|---------------------------------------------------------------|
| CAD/CAM Software Version | |
| CEREC SW Chairside CAD/CAM Software | CEREC SW Chairside CAD/CAM Software |
| Acquisition Units | |
| CEREC AC | CEREC AC |
| CEREC AC Connect | CEREC AC Connect |
| CEREC Omnicam 3D digital intraoral scanner | CEREC Omnicam 3D digital intraoral scanner |
| Milling Unit | |
| CEREC MC | CEREC MC |
| CEREC MC X | CEREC MC X |
| CEREC MC XL | CEREC MC XL |
| CEREC MC XL Premium | CEREC MC XL Premium |
| Titanium Base Components | |
| Sirona TiBase | Sirona TiBase |
| Diameter: 3.0 mm - 7.0 mm | Diameter: 3.0 mm - 7.0 mm |
| Maximum Angulation of Finished Abutment: | Maximum Angulation of Finished Abutment: |
| 20° | 20° |
| Material (TiBase and Screw) | Material (TiBase and Screw) |
| Titanium alloy | Titanium alloy |
| Mesostructure material | |
| Sirona inCoris ZI zirconium blocks | Sirona inCoris ZI zirconium blocks |
| Block Material: | Block Material: |
| Zirconium oxide ceramic | Zirconium oxide ceramic |
| Block Dimensions: | Block Dimensions: |
| 24 mm (L) x 23 mm (W) x 21.5 mm (H) | 24 mm (L) x 23 mm (W) x 21.5 mm (H) |
| Available Shades: | Available Shades: |
| F0.5, F2 | F0.5, F2 |
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7. Non-Clinical Performance Data
Testing to verify the performance requirements of the modified Sirona Dental CAD/CAM System with CEREC Chairside Software was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.
Tests included in this premarket notification:
- Geometric compatibility of the implant to the TiBase connection implant connection . interface is confirmed for the subject new Sirona TiBase components via direct access to the original manufacturer's implant geometry specifications for the Dentsply Sirona, OsseoSpeed TX implant system. Because the implant to TiBase interface connection geometry of the proposed Sirona TiBase component for this system was designed through direct reference to the original implant design specifications, no reverse engineering analysis was conducted.
- . Dynamic fatigue testing of new TiBase variants in worst-case construct according to ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants) was conducted. The test design included test sample constructs fabricated at the maximum allowable abutment angulation and utilizing TiBase components exhibiting the worst-case design with respect to implant connection interface geometry.
- . New TiBase variants are composed of the identical materials and are fabricated utilizing the same methods as the components cleared under K181520. Therefore, no new biocompatibility data is included to support the substantial equivalence of the modified Sirona Dental CAD/CAM System.
- The recommended steam sterilization parameters for the new TiBase components included in the line extension as subject to this premarket notification are identical to the validated steam sterilization parameters recommended for the TiBase components included with the predicate device as cleared under premarket notification K181520. The validation of the recommended steam sterilization parameters was conducted according to 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 with reference to ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 and A4:2013: Comprehensive guide to steam sterilization and sterility assurance in health care facilities and the original validation of the recommended parameters is referenced in this premarket notification in support of substantial equivalence.
- . Software system integration testing was conducted to validate the system requirements associated with the introduction of the TiBase component line extension as selectable within the CEREC Chairside CAD/CAM software for the design and fabrication of two-piece CAD/CAM dental abutments. No modification to the CEREC CAD/CAM abutment design software's controls limiting the critical abutment design parameters are introduced in this premarket notification.
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8. Clinical Performance Data
No human clinical data was included in this premarket notification to support the substantial equivalence of the modified Sirona Dental CAD/CAM System with CEREC Chairside Software.
9. Conclusion Regarding Substantial Equivalence
The information included in this premarket notification supports the substantial equivalence of the modified Sirona Dental CAD/CAM System with CEREC Chairside Software. The modified device which is the subject of this premarket notification has the identical intended use as the legally marketed predicate device cleared under premarket notification K181520. The modified device also has similar indications for use and incorporates the same fundamental technology as the predicate device (K181520).
Performance testing was conducted to demonstrate the performance of the modified Sirona Dental CAD/CAM System with CEREC Chairside Software with the line extension of the TiBase offerings. The results of the testing included in this premarket notification support a determination of substantial equivalence with the additional TiBases offered.