Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.

Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for:

Fixed partial dentures/splinted units (one implant per unit)
Pontic cases in combination with at least one longer implant
Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

Device Description

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222.

The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.

AI/ML Overview

The provided text does NOT describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing (such as AI assistance effect size, ground truth for training/test sets, sample sizes for training/test sets, adjudication methods, and expert qualifications) cannot be extracted or fulfilled.

The document pertains to the 510(k) summary for Straumann® 4 mm Short Implants, a medical device, and the evaluation details focus on the physical and mechanical performance of the implant, biocompatibility, sterilization, and clinical literature review of implant survival rates, not on an AI system's performance.

Therefore, the table of acceptance criteria and reported device performance, and the other requested information points are not applicable in the context of an AI/ML device. The document describes a dental implant, not an AI or imaging device.

Summary

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Straumann USA, LLC Jennifer Jackson Director, Regulatory Affairs 60 Minuteman Road Andover, Massachusetts 01801

Re: K202942

Trade/Device Name: Straumann® 4 mm Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 9, 2020 Received: November 10, 2020

Dear Jennifer Jackson:

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.

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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 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.

Andrew Steen Assistant 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202942

Device Name

Straumann® 4 mm Short Implants

Indications for Use (Describe)

The 4 mm Short Implants are specifically recommended for:

. Fixed partial dentures/splinted units (one implant per unit)
Pontic cases in combination with at least one longer implant
Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the ● anterior region and at least four total implants

Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

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Straumann® 4 mm Short Implants

510(k) Summary

5 510(k) Summary

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023
Prepared By &Alternate Contact:	Chanrasmey White, MSRegulatory Affairs SpecialistStraumann, USA, LLCPhone Number: +1 978 747-2516Fax Number: +1 978 747-0023
Date of Submission:	February 8. 2021

5.2 Name of the Device

Trade Names:	Straumann® 4 mm Short Implants
Common Name:	Endosseous Dental Implant
Classification Name:	Endosseous Dental Implant
Regulation Number:	§872.3640
Device Classification:	II
Product Code(s):	DZE
Classification Panel:	Dental

Predicate Device(s) 5.3

Primary Predicate:

K130222, Straumann Dental Implant System .

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Straumann® 4 mm Short Implants

510(k) Summary

Reference Devices:

K092035, Bicon Implants with a 2.5 mm Internal Connection .
. K123022, Neodent Implant System
K190662, MRI Compatibility for Existing Straumann Dental Implant Systems .

5.4 Device Description

5.5 Intended Use

Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.

5.6 Indications for Use

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Straumann® 4 mm Short Implants

510(k) Summary

Fixed partial dentures/splinted units (one implant per unit) .
. Pontic cases in combination with at least one longer implant
Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 . longer implants in the anterior region and at least four total implants

5.7 Technological Characteristics

There are no changes to the materials, surface treatments, fundamental operating principles, or sterilization processes or procedures as a result of the proposed changes. The subject devices have a new implant length of 4 mm. The technological characteristics of the subject device are compared to the primary predicate and reference devices in Table 1.

Table 1 addresses the similarities and differences between the subject and predicate device. The subject device has more restrictive Indications for Use compared to the primary predicate. The differences in the Indications for Use are to address the short length of the implant and are narrower than the primary predicate device. Performance testing and clinical data provided demonstrates equivalency in product performance.

No new surgical instruments are being introduced. No new secondary components (i.e., abutments, closure screws, etc.) are being introduced as the currently cleared portfolio is compatible with the subject devices.

The reference device K190662 is included for reference to the MRI compatibility.

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Straumann® 4 mm Short Implants

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	Straumann® 4 mm ShortImplants(K202942)	Straumann® Dental ImplantSystem(K130222)	Neodent Implant System(K123022)	Bicon Implants with 2.5 mmInternal Connection(K092035)
Indications forUse	Straumann® 4 mm Short Implantsare indicated for fixed orremovable reconstruction insituations of moderate toseverely atrophic jawbone andwith adequate bone quality thatallows primary stability afterimplant insertion, where a longerimplant cannot be placed due tolimited vertical bone height. Therecommended healing timebefore loading is between 10 to12 weeks.The 4 mm Short Implants arespecifically recommended for:● Fixed partialdentures/splinted units(one implant per unit)● Pontic cases incombination with atleast one longer implant● Fully edentulous caseswith at least one 4 mmShort Implant incombination with 2longer implants in theanterior region and atleast four total implants	Straumann® dental implants areindicated for oral endostealimplantation in the upper andlower jaw arches for thefunctional and aesthetic oralrehabilitation of edentulous andpartially dentate patients.Straumann® dental implants arealso indicated for immediate orearly implantation followingextraction or loss of naturalteeth. Implants can be placedwith immediate function onsingle-tooth and/or multipletooth applications when goodprimary stability is achieved andwith appropriate occlusalloading, to restore chewingfunction. The prostheticrestorations used are singlecrowns, bridges and partial orfull dentures, which areconnected to the implants by thecorresponding components(abutments).	The Neodent Implant System isintended to be surgically placedin the bone of the upper or lowerjaw to provide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage or two-stage procedures, for single ormultiple unit restorations, andmay be loaded immediatelywhen good primary stability isachieved and with appropriateocclusal loading. Titamax WSimplant is indicated for adelayed loading protocol. TheFacility implant is indicated forreplacement of maxillary lateralincisors, mandibular incisors orretention of overdentures.	The Bicon implant is designedfor use in edentulous sites in themandible or maxilla for supportof a complete dentureprosthesis, a final orintermediate abutment for fixedbridgework or for partialdentures, or as a single toothreplacement.
Material	Roxolid® (Ti-Zr alloy)	Roxolid® (Ti-Zr alloy)	Commercially pure titanium,Grade 4	Surgical grade titanium alloy (Ti-6Al-4V)
SurfaceTreatment	SLActive®	SLActive®	Grit blasted, acid etched	Grit blasted, acid etched, andhydroxylapatite
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	Straumann® 4 mm ShortImplants(K202942)	Straumann® Dental ImplantSystem(K130222)	Neodent Implant System(K123022)	Bicon Implants with 2.5 mmInternal Connection(K092035)
ApicalDiameter	Ø4.1 and Ø4.8 mm	Ø4.1 and Ø4.8 mm	Ø3.3, Ø4.3, and Ø5.3 mm	Ø4.0
CoronalDiameter	Ø4.8 and Ø6.5 mm	Ø4.8 and Ø6.5 mm (TL)Ø4.1 and Ø4.8 mm (BL)	Ø4.0, Ø5.0, and Ø6.0 mm	Unknown
Length	4 mm	6, 8, 10, 12, 14, and 16 mm (TL)8, 10, 12, and 14 mm (BL)	5 and 6 mm	5 mm
Implant Design	Cylindrical	Cylindrical	Cylindrical	Cylindrical
Implant NeckHeight	1.8 mm, smooth machined	1.8 mm, smooth machined (TL)None (BL)	None	None
Thread Pitch	0.8 mm	1.25 mm (TL)0.8 mm (BL)	0.6 mm (Ø4.0)0.8 mm (Ø5.0 and Ø6.0)	Unknown
Implant/AbutmentConnection	8° cone, internal octagon, 45°shoulder	8° cone, internal octagon, 45°shoulder (TL)15° cone, 4 grooves/protrusions(BL)	Morse taper	Locking Taper
CompatibleAbutments	Straight Abutments	Straight and angled abutments	Straight abutments	Straight and angled abutments
HealingProtocol	10-12 weeks	3-4 weeks	No immediate loading	10-12 weeks

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Straumann® 4 mm Short Implants

510(k) Summary

Table 1 – Comparison Matrix

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Straumann® 4 mm Short Implants

510(k) Summary

5.8 Performance Testing

The following performance data support the substantial equivalence determination.

5.8.1 Sterilization Validation and Shelf Life

The implants will be provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum and will be sterilized after packaging. A sterility assurance level (SAL) of 10° had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2006. Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.

The packaging of the subject devices is identical to the packaging of the primary predicate device and the shelf life is 5 years when considering that the materials are not adversely affected by time.

There are no changes to the sterilization method or processes when compared to the Straumann predicate devices.

Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The subject devices will not be labeled as non-pyrogenic. The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.

5.8.2 Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.

The subject devices have the identical nature of body contact, contact duration, material formulation and sterilization methods compared to the primary predicate devices.

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Straumann® 4 mm Short Implants

510(k) Summary

5.8.3 Performance Testing - Bench

Evaluation of the endosseous surface area was conducted for the subject devices as well as the primary predicate and reference devices. The surface areas were evaluated for the total endosseous surface, initial bone-to-implant contact, as well as with simulated 1 and 2 mm of bone loss.

Dynamic fatigue tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and a modified ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants) test set-up due to the length of the subject devices. The test environment for the subject devices was ambient air. The Straumann® 4 mm Short Implants met the defined acceptance criteria and the mechanical strength requirements for its intended use. The results of the dynamic fatigue testing demonstrated the subject devices are equivalent to the primary predicate devices.

5.8.4 Performance Testing - Clinical

A review and summary of published clinical literature evaluating the use of 4 mm short implants in fully and partially edentulous adult patients and a summary of the complaint trends and vigilance reporting associated with the use of Straumann 4 mm short dental implants has been submitted to support substantial equivalence. Parameters evaluated in the clinical literature provided included study name, number of study participants, number of implants placed, duration of follow-up (in years); implant placement site, implant failures, survival rates and alveolar bone loss.

The clinical literature represents 57 cases with 118 implants of 4.1 mm diameter x 4 mm length, with 12 to 27 months of follow-up. Clinical cases in the literature were represented by the following patient scenarios:

. Fixed partial dentures/splinted units (one implant per unit)
. Pontic cases in combination with at least one longer implant
. Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
Delayed loading .

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Straumann® 4 mm Short Implants

510(k) Summary

Survival rates were at least 90%, with most failures attributed to early loss. This is comparable with data from 6 mm implants, in which the mean failure rate was 93.7%, also with most failures attributed to early loss. The available data indicates the subject dental implants may be used reliably and predictably with comparable survival and success rates to the primary predicate devices.

Post-market assessment via complaint trends and vigilance reporting data reflected 42,760 sales of 4.1 mm diameter x 4 mm length implants and 12,119 sales of 4.8 mm diameter x 4 mm length implants from September 2013 to September 2020. The overall complaint rate was 4.20% to 4.47%, with 3.41% to 3.84% of cases due to early loss. This is comparable with data from the primary predicate (implants with the same diameters but with 6 mm length), in which the overall complaint rate ranged from 3.00% to 4.07%, with early loss accounting for 2.27% to 2.57% of cases.

The results being presented in this premarket notification meet the definition of valid scientific data as defined in 21 CFR 860.7. The results are being presented in accordance with the guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Abutments".

The clinical data suggest performance of the Straumann® 4 mm Short Implants is equivalent to the primary predicate device if used according to the indications for use.

Conclusion 5.9

The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.