The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Device Description

The Straumann® Variobase® for CEREC® abutments provide the interface for copings or crowns designed and milled using the Sirona CEREC system with four of the Straumann dental implant platforms: RN (Reqular Neck), WN (Wide Neck), RC (Regular CrossFit®), and NC (Narrow CrossFit®). The Straumann® Variobase® for CEREC® abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above.

AI/ML Overview

The provided text is a 510(k) summary for the Straumann® Variobase® for CEREC® abutments. It details the device, its intended use, and comparative analysis with predicate devices, along with performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit, pre-defined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, which are common for AI/diagnostic devices. Instead, it demonstrates "substantial equivalence" to predicate devices through various performance tests.

Here's what can be inferred about the performance goals and the results reported:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Dimensional Fit (Coping on Abutment)	Confirmed appropriate fit of the milled coping on the abutment using CEREC® e.max blocks.
Dynamic Fatigue Properties	Demonstrated compliance with minimum required fatigue properties for abutments with cemented e.max CADCAM coping (Worst-case testing).
Process Validation (Workflow)	Validation of the Straumann® Variobase® for CEREC® within the Sirona CEREC® InLab workflow.
Sterilization Validation	Validation according to ISO 17665-1, ISO/TR 17665-2, and ANSI/AAMI ST79.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for specific tests in terms of number of cases, patients, or data points in a way that would be typical for an AI-driven diagnostic.

Dimensional verification: "CEREC® e.max blocks" are mentioned, implying physical components were tested, but no number is given.
Dynamic fatigue testing: "Worst case dynamic fatigue testing" is mentioned, implying a specific test methodology, but the sample size (e.g., number of abutments tested) is not provided.
Process validation: Relates to the workflow, not a data set.
Sterilization validation: Refers to compliance with standards, not performance on a data set.

The provenance of data is not applicable in the context of this device, as it's a dental implant abutment, not a data-driven diagnostic or AI device. The testing focuses on physical and functional characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The device is a physical dental hardware component (abutment) and its compatibility with a CAD/CAM system, not an AI or diagnostic application requiring expert review for ground truth establishment. The "ground truth" for the performance tests would be objective measurement standards (e.g., ISO for sterilization, mechanical testing standards for fatigue).

4. Adjudication Method for the Test Set

This information is not applicable as the device is not an AI/diagnostic device. Performance tests involve objective measurements and adherence to standards, not subjective expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is a physical medical device (dental abutment), not a diagnostic or AI system that human readers would interact with. Therefore, there's no "human readers with/without AI assistance" scenario.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical component, not an algorithm. The "algorithm" aspect refers to the Sirona CAD/CAM software used to design the copings/crowns that interface with the abutment, and the document clarifies that the device (abutment) is compatible with existing, cleared software versions. The abutment itself does not perform any algorithmic function.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing consists of:

Physical Fit Standards: For dimensional verification (e.g., CAD specifications, manufacturing tolerances).
Mechanical Performance Standards: For dynamic fatigue testing (e.g., ISO standards for dental implants and prosthetics that define minimum required fatigue properties).
Process Standards: For process validation (Sirona CEREC InLab workflow parameters).
Sterilization Standards: For sterilization validation (ISO 17665-1, ISO/TR 17665-2, ANSI/AAMI ST79).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI algorithm that requires a training set. The reference to Sirona software versions (3.65 and 4.2 or higher) indicates compatibility with existing, validated software, not training a new model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this physical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2015

Straumann USA LLC c/o Ms. Sheila Hemeon-Heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K151324

Trade/Device Name: Straumann® Variobase® for CEREC®, Abutment Models RN, WN, RC, NC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 12, 2015 Received: August 13, 2015

Dear Ms. Hemeon-Heyer:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151324

Device Name

Straumann® Variobase® for CEREC®, Abutment Models RN, WN, RC, NC

Indications for Use (Describe)

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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Section 6: 510(k) Summary

510(k) Summary

K151324

Submitter's Contact Information 6.1

Submitter Name:	Straumann USA, LLC (on behalf of Institut Straumann AG)
Address:	60 Minuteman RoadAndover, MA 01810
Phone Number:	1-978-747-2575
Fax Number:	1-978-747-0023
Contact Person:	Christopher Klaczyk
Date of Summary:	September 10, 2015

6.2 Name of the Device

Trade Name:	Straumann® Variobase® for CEREC®, Abutment Models RN, WN,RC, NC
Common Name:	Dental Implant Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation & Class:	21 CFR §872.3630, Class II
Product Code:	NHA

Predicate Devices 6.3

Primary Predicate:

. K142890, Straumann® Variobase® Abutments, Models NNC, RN, WN, RC, NC
Reference Predicate(s):
K100152, Sirona Dental CAD/CAM System (introduction of the Sirona SSO series . Ti-bases compatible with the Straumann Tissue Level implants and introduction of the CEREC MC X and MC XL and inLab MC X and MC XL mills)
K111421, Sirona Dental CAD/CAM System (introduction of the Sirona SBL series ● Ti-bases compatible with the Straumann Bone Level implants)

Device Description 6.4

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Section 6: 510(k) Summary

CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above. The new components introduced in this 510(k) are shown below.

Straumann® Variobase® for CEREC® Abutments
Image: RN	Image: WN	Image: RC	Image: NC
RN	WN	RC	NC

Catalog Number	Description
022.0019	RN Variobase® for CEREC®
022.0020	WN Variobase® for CEREC®
022.0024	RC Variobase® for CEREC®
022.0025	NC Variobase® for CEREC®
022.0045	RN/WN Basal screw for Variobase®*

The Straumann® Variobase® for CEREC® abutments are compatible with the following previously cleared materials:

. inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrO2) cleared to market per K062509 and K123664
. IPS e.max CAD Abutment Solutions (Ivoclar IPS e.max CAD lithium disilicate glass-ceramic, LS2) cleared to market per K132209
Telio CAD (Ivoclar Telio CAD polymethylmethacrylate, PMMA) cleared to . market per K093708

The Straumann® Variobase® for CEREC® abutments are compatible with copings and crowns fabricated using the following previously cleared mills:

Sirona Dental CAD/CAM System (introduction of the Sirona SSO series Ti-. bases compatible with the Straumann Tissue Level implants and introduction of the CEREC MC X and MC XL and inLab MC X and MC XL mills) cleared to market per K100152
Sirona Dental CAD/CAM System (introduction of the Sirona SBL series Ti-● bases compatible with the Straumann Bone Level implants) cleared to market per K111421

Straumann has verified that the functionality necessary to design and produce abutments compatible with the Straumann Variobase for CEREC abutments (as well as the Sirona SSO and SBL series Ti-bases) has been present in the Sirona CEREC Software since

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Section 6: 510(k) Summary

version 4.2 (released May 2013) and in the Sirona inLab Software since version 3.65 (released January 2012). Copings and crowns designed using these or more recent versions of the Sirona software, within the design limits as defined within the design software, are compatible with the Straumann Variobase for CEREC abutments.

6.5 Indications For Use

6.6 Substantial Equivalence and Performance Testing

The Straumann® Variobase® for CEREC® are made of the same TAN alloy material and the same base design as primary predicate Straumann® Variobase® Abutments previously cleared for the Straumann® implant platforms RN, WN, RC and NC. The only difference is that the coronal portion of these abutments has been designed to interface with the milling blanks used to create copings and crowns with the Sirona CEREC® CAD/CAM system. The new design assures dimensional matching of the CEREC® restorations with the Straumann Variobase for CEREC ®abutments and provides an interlocking feature to augment the cemented adhesion of the restoration onto the abutment.

The subject Straumann Variobase for CEREC abutments are functionally equivalent to the reference predicate Sirona SSO series Ti-base abutments previously cleared to market per K100152 and the reference predicate Sirona SBL series Ti-base abutments previously cleared to market per K111421. The Sirona SSO series Ti-bases have been shown by Sirona to be compatible with Straumann Tissue Level implants and the Sirona SBL series Ti-bases have been shown by Sirona to be compatible with Straumann Bone Level implants. The coronal geometry of the subject devices is equivalent to the coronal geometry of the reference predicates, therefore copings and crowns fabricated using the Sirona software and milling systems will be compatible with the subject devices.

The following performance testing was submitted in this 510(k) to support substantial equivalence:

Dimensional verification using CEREC® e.max blocks, which confirmed the . appropriate fit of the milled coping on the abutment
. Worst case dynamic fatigue testing demonstrating compliance with the
minimum required fatigue properties of the Straumann® Variobase® for CEREC® .
abutments with cemented e.max CADCAM coping ●
Process validation of the Straumann® Variobase® for CEREC® within the Sirona . CEREC® InLab workflow

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Section 6: 510(k) Summary

Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ● ANSI/AAMI ST79
There have been no changes to the materials, packaging, or recommended sterilization method/parameters for these devices as compared to the primary predicate devices.

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Straumann® Variobase® for CEREC® Traditional 510(k)

Section 6: 510(k) Summary

FEATURE	SUBJECT DEVICEStraumann Variobase forCEREC Abutments	PRIMARY PREDICATEStraumann VariobaseAbutments (K142890)	EQUIVALENCEDISCUSSION
Intended Use	Intended to be placed intoStraumann dental implants toprovide support for prostheticreconstructions such ascrowns.	Prosthetic components directlyconnected to the endosseousdental implant are intended foruse as an aid in prostheticrehabilitations.	Substantially equivalent
Indications forUse	The Straumann® Variobase® forCEREC® are titanium alloyabutments placed ontoStraumann dental implants toprovide support for customizedprosthetic restorations.Straumann® Variobase® forCEREC® abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations.All digitally designed copingsand/or crowns for use with theStraumann® Variobase® forCEREC® abutments are to bedesigned using Sirona inLabsoftware (Version 3.65 or higher)or Sirona CEREC Software(Version 4.2 or higher) andmanufactured using a SironaCEREC or inLab MC X or MC XLmilling unit.	The Straumann® Variobase™Abutment is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. Straumann®Variobase™ Abutments areindicated for screw-retainedsingle tooth or cement- retainedsingle tooth and bridgerestorations.All digitally designed copingsand/or crowns for use with theStraumann® Variobase™Abutment system are intended tobe sent to Straumann formanufacture at a validatedmilling center.	Different workflows used todesign and fabricate therestorations. Coronal aspect ofproposed device is designed tointerface with copings/crownsfabricated from milling blankscontaining pre- machined holesfor use with the CERECCADCAM system. Substantialequivalence based on designvalidation testing.
FEATURE	SUBJECT DEVICEStraumann Variobase forCEREC Abutments	PRIMARY PREDICATEStraumann VariobaseAbutments (K142890)	EQUIVALENCEDISCUSSION
Contraindications	Patients with known allergies orhypersensitivity to chemicalingredients of the followingmaterials used: titanium (Ti),titanium alloy Ti6Al7Nb(titanium-aluminum-niobium orTAN)	Allergies or hypersensitivity tomaterials used: Titanium alloyTi-6Al-7Nb (titanium- aluminum-niobium or TAN).	Same
Ti-baseMaterial	Titanium-Aluminum-Niobiumalloy (Ti-6Al-7Nb)	Titanium-Aluminum-Niobiumalloy (Ti-6Al-7Nb)	Same
AbutmentDiameter (base)	4.5 mm - 7.0 mm	3.8 mm - 7.0 mm	Substantially equivalentProposed device models donot include NNC (3.8 mm dia)
Abutment Height	4.7 mm	3.5 – 4.5 mm	Substantially equivalent
Coping/ CrownMaterial	Compatible with any millingblanks cleared for use with theCEREC MC X and MC XLmilling systems (i.e., containingthe pre-machined mountinghole). Currently available:inCoris ZI meso (K123664)Ivoclar IPS e.max CAD(K132209)Ivoclar Telio CAD (K093708)	TraditionalWorkflow:Type 4 Metals (ISO 22674) IPSe.max® Press Ceramic DigitalWorkflow:polycon® ae (temporary)zerion® (permanent)IPS e.max® CAD Ceramic(permanent)coron® (permanent)	Substantially equivalentAll materials to be used forcoping/crown have previouslybeen cleared and are not thesubject of this510(k).
Design Workflow	Per the Sirona CEREC InLab,software version 3.6 or later	Wax-up or Open CAD	Substantially equivalent
FEATURE	SUBJECT DEVICEStraumann Variobase forCEREC Abutments	PRIMARY PREDICATEStraumann VariobaseAbutments (K142890)	EQUIVALENCEDISCUSSION
ManufacturingWorkflow	Per the Sirona Cerec MC Xand MC XL milling systems	Traditional casting orpressing or StraumannMilling	Substantially equivalent
Mode of Attachment	Screw-retained or cementretained	Screw-retained or cementretained	Same
Reusable	No	No	Same

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Straumann® Variobase® for CEREC® Traditional 510(k)

Section 6: 510(k) Summary

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Straumann® Variobase® for CEREC® Traditional 510(k)

Section 6: 510(k) Summary

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Section 6: 510(k) Summary

6.7 Conclusion

The documentation submitted in this premarket notification demonstrates that the Straumann® Variobase® for CEREC® abutments are substantially equivalent to the primary predicate Straumann® Variobase® Abutments and the reference predicate Sirona Ti-base devices previously cleared as being compatible with the implants of the Straumann Dental Implant System.

Regulation Number and Section

§ 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.)