Straumann Immediate Temporary Abutments by Institut Straumann AG

The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.

The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.

Device Description

The Straumann Immediate Temporary Abutment and associated Plastic Copinq consist of a titanium abutment and PMMA coping for the Straumann dental implants BL, BLT and BLX. The abutments are available in a variety of gingival heights and diameters to fit individual patient situations. The PMMA coping is compatible with the subject Immediate Temporary Abutments. The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.

AI/ML Overview

The provided text is a 510(k) summary for the Straumann® Immediate Temporary Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative performance study context.

Therefore, many of the requested sections about acceptance criteria, specific reported device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance studies are not explicitly detailed in the provided text, as these are typically part of a different type of submission (e.g., a PMA or scientific publication).

However, I can extract information related to the functional characteristics and the types of testing performed to support the substantial equivalence.

Here's an attempt to answer your request based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of a performance study with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating equivalence to predicate devices through various tests.

The "acceptance criteria" here are implicitly meeting the standards of the predicate devices and relevant ISO standards. The "reported device performance" is a statement that these standards and equivalence have been met.

Acceptance Criteria (Implicit by Equivalence/Standards)	Reported Device Performance (as stated in the document)
Biocompatibility according to ISO 10993-1:2009	Assessed and found equivalent to predicate devices. Cytotoxicity (ISO 10993-5:2009) and Chemical Analysis (ISO 10993-18:2020) and toxicology evaluation performed for PMMA coping, concluding biocompatibility.
Sterilization validation according to ISO 11137	Assessment concluded adoption into validated process for reference predicate (K192401) is appropriate.
High-level disinfection efficacy for PMMA coping	Validation performed on worst-case PMMA device; subject coping can adopt this validation.
MRI Conditional compatibility	MRI Conditional; does not introduce new material or worst-case scenario over reference device K190662.
Mechanical integrity/performance (implied under benchmarking with predicate)	Differences in technological characteristics (e.g., one-piece design, abutment diameter) "addressed in the performance testing provided in this submission which demonstrates equivalency in product performance." (Specific results not given in this summary).
Duration of Use (180 days)	Biocompatibility testing performed to support the 180-day duration of use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide details on specific sample sizes for test sets used in the various performance tests (biocompatibility, sterilization, disinfection, or implied mechanical testing). The data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These types of details are usually found in the full test reports, not typically in the 510(k) summary.

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)

This is not applicable to the type of device and testing described. The "ground truth" for this medical device (dental abutment) is established through adherence to engineering standards, material science, and biological safety guidelines, rather than expert clinical interpretation of data (like in imaging diagnostics).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for the physical and biological testing of a dental abutment.

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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiologists, pathologists) often assisted by AI. This device is a physical dental abutment.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on established engineering and material science standards (e.g., ISO for biocompatibility and sterilization), and the performance characteristics of predicate devices. For instance, the biocompatibility testing assesses the device against accepted safety limits for biological responses.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML device.

Summary

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March 18, 2021

Institut Straumann AG % Chanrasmey White Regulatory Affairs Specialist Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K201681

Trade/Device Name: Straumann Immediate Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 12, 2021 Received: February 16, 2021

Dear Chanrasmey White:

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201681

Device Name Straumann® Immediate Temporary Abutments

Indications for Use (Describe)

The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Straumann® Immediate Temporary Abutments

510(k) Summary

K201681 510(k) Summary 5

Submitter 5.1

60 Minuteman Road

Andover, MA 01810

978-747-0023 Fax Number:

Contact Person: Chanrasmey White
March 17, 2021 Date of Prepared:

5.2 Device

Trade Name:	Straumann® Immediate Temporary Abutments
Common Name:	Endosseous Dental Implant Abutments
Classification Name:	Endosseous Dental Implant Abutments
Regulatory Class:	II (21 CFR 872.3630)
Product Code:	NHA (21 CFR 872.3630)

5.3 Predicate Device

Primary Predicate:

K122192 Straumann Temporary Abutments, PMMA
Reference Predicate:
K192401 Straumann Screw Retained Abutments
K181703 BLX Implant System
K190662 MRI Compatibility for Existing Straumann Dental Implant System
K041070 Straumann Temporary Coping

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Straumann® Immediate Temporary Abutments

510(k) Summary

Device Description 5.4

5.5 Indications for Use

The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.

The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.

5.6 Technological Characteristics

The subject device is equivalent to the primary predicate and reference devices sharing the same material and fundamental operating principles. The differences in indications for use are addressed in performance testing provided in this submission demonstrating equivalent product performance. The subject and the primary predicate devices are intended to support temporary prosthetic reconstructions. The subject devices have a contact duration of up to 180 days compared to the primary predicate and reference devices, biocompatibility testing has been performed to support the 180 duration of use. The technological characteristics of the subject device are compared to the primary predicate and reference devices in Table 2. The subject devices are one-piece abutments opposed to the two-piece temporary abutments cleared per K122192. The one-piece design allows the abutment to be directly screwed into the

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Straumann® Immediate Temporary Abutments

510(k) Summary

implant. The differences in technological differences are addressed in the performance testing provided in the submission which demonstrates equivalency in product performance.

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Straumann® Immediate Temporary Abutments

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	Subject Device	K122192	K192401	K181703
Indications for Use	The Straumann ImmediateTemporary Abutment andassociated Plastic Coping areindicated to beplaced into Straumann dentalimplants (BL, BLT or BLX) toprovide a support structure for atemporaryaesthetic oral rehabilitation ofpartially edentulous patients withcrowns. Temporary componentscan be used prior to the insertionof the final components tomaintain, stabilize and shape thesoft tissue during the healingphase for up to 180 days.The Straumann ImmediateTemporary Abutment andassociated Plastic Coping must beplaced out of occlusion.	Straumann Temporary AbutmentsVITA CAD-Temp are indicated foruse with Straumann Bone Leveland Tissue Level implants fortemporary crown and bridgerestorations, and to maintain,stabilize and shape the soft tissueduring the healing phase for up tosix months, and should be placedout of occlusion.	Prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize and shape the soft tissueduring the healing phase; they maynot be placed into occlusion. Finalabutments may be placed intoocclusion when the implant is fullyosseointegrated.Temporary Abutments have amaximum duration of usage of 180days.	Straumann® BLX ImplantsStraumann® BLX Implants aresuitable for endosteal implantationin the upper and lower jaw and forthe functional and esthetic oralrehabilitation of edentulous andpartially edentulous patients. BLXImplants can be placed withimmediate function on single-tooth.bar and bridge applications whenqood primary stability is achievedand with appropriate occlusalloading to restore chewingfunction. The prostheticrestorations are connected to theimplants through thecorresponding abutmentcomponents.Straumann® BLX SRAs andAnatomic AbutmentsProsthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize and shape the soft tissueduring the healing phase; they maynot be placed into occlusion. Finalabutments may be placed intoocclusion when the implant is fullyosseointegrated. BLX TemporaryAbutments have a maximumduration of usage of 180 days.
Material	Abutment:Ti-6Al-7NbPlastic Coping:Polymethyl Methacrylate (PMMA)	Ti-6Al-7NbPolymethyl Methacrylate (PMMA)	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant Compatibility	BL, BLT, BLX	BL, BLT, TL	BL, BLT	BLX
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K Number	Subject Device	K122192	K192401	K181703
Abutment Diameter	Ø3.8 and 4.5	Ø5.0, 7.0, and 10.0 mm	Ø3.5 and 4.6 mm	Ø4.6 mm
Gingival Heights	BL and BLT - 1, 2, and 3 mmBLX - 1.5, 2.5, and 3.5 mm	1.0, 2.5, 4.0, and 5.5 mm	1.5, 2.5, 3.5, 4.5, and 5.5 mm	1.5, 2.5, 3.5, and 4.5 mm
Abutment Angulation	0°	0°	0, 17 and 30°	0, 17 and 30°
Indexing Type/Presence	Non-Engaging	Engaging	Straight - Non-Engaging	Straight - Non-Engaging
Integrated ScrewTechnology	YesMachined one-piece	NoCoupled with a base screw	Yes - The straight abutments aremachined one-piece	Yes - The straight abutments aremachined one-piece
Restoration Type	Cemented	Cemented	Screw-retained	Screw-retained
Duration of Use	180 days	180 days	unlimited	unlimited
Sterilization	Sterile - Gamma Irradiation	Non-SterileEnd User - Steam Autoclave	Sterile - Gamma Irradiation	Sterile - Gamma Irradiation
Loading	Single Unit	Single and Multi Unit	Single and Multi Unit	Single and Multi Unit

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Straumann® Immediate Temporary Abutments

510(k) Summary

Table 1 – Immediate Temporary Abutment – Comparison Matrix

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Straumann® Immediate Temporary Abutments

510(k) Summary

FEATURE	PROPOSED DEVICE	REFERENCE DEVICE
K Number	Subject Device	K041070
Indications for Use	The Straumann Immediate TemporaryAbutment and associated Plastic Coping areindicated to be placed into Straumann dentalimplants (BL, BLT or BLX) to provide a supportstructure for a temporary aesthetic oralrehabilitation of partially edentulous patientswith crowns. Temporary components can beused prior to the insertion of the finalcomponents to maintain, stabilize and shapethe soft tissue during the healing phase for upto 180 days.The Straumann Immediate TemporaryAbutment and associated Plastic Coping mustbe placed out of occlusion.	Temporary Copings are intended to serve as abase for temporary restorations.
Material	Polymethyl methacrylate (PMMA)	Polymethyl methacrylate (PMMA)
Restoration Type	Cemented	Cemented
Duration of Use	180 days	30 days
Sterilization	Non-SterileCleaned and disinfected	Non-Sterile

Table 2 – Plastic Coping – Comparison Matrix

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Straumann® Immediate Temporary Abutments

510(k) Summary

Performance Data 5.7 -

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The subject devices have been assessed for biological safety 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 the subject device. The subject abutments are equivalent with regard to nature of body contact, duration of use, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore, no new testing have been performed as biocompatibility is represented in the primary and reference predicate devices.

In support of the subject PMMA plastic copings, Cytotoxicity testing according to ISO 10993-5:2009, "Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity" and Chemical Analysis according to ISO 10993-18: 2020 "Chemical characterization of medical device materials within a risk management process" has been performed. In addition to the above testing a toxicology evaluation has been performed in support of the subject PMMA plastic copings. The test and evaluation performed the biocompatibility of the subject PMMA plastic copings.

Sterilization

The subject device are single patient devices. The Immediate Temporary Abutments will be delivered in a sterile packaging via Gamma Irradiation and the PMMA plastic coping will be delivered non-sterile. The PMMA plastic coping is to be manually cleaned and disinfected according to the Instructions for Use.

A sterilization validation assessment was performed according to ISO 11137 for the Immediate Temporary Abutments. The assessment concluded the proposed Immediate Temporary

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Straumann® Immediate Temporary Abutments

510(k) Summary

Abutment can be adopted into the same sterilization process validated for the Straumann Sterile Prosthetics cleared for reference predicate K192401.

A high-level disinfectant validation was performed on the worst case PMMA device. The worst case was selected based on the most challenging designs for high level disinfection process due to size, surface, complexity and accessibility of the liquid solution. The subject PMMA Plastic Coping is not considered a new worst case and therefore can adopt the validation demonstrating the high-level disinfectant cleaning method can effectively disinfect the Plastic Coping.

The packaging of the Straumann® Immediate Temporary Abutments is identical to the packaging of the reference device K192401. There are no changes to the sterilization method or production process compared to the reference device. The shelf life for the proposed devices is 5 years identical to the reference device.

Bench Testing

The subject devices are MRI Conditional and do not introduce a new material or worst-case scenario and is represented under reference device K190662.

Conclusion 5.8

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

§ 872.3630 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.)