Healing Caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.

Device Description

The Healing Caps are screws machined into 2 pieces and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is yttria-stabilized tetragonal zirconia (Y-TZP) and titanium grade 4. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Straumann® CI RD Ceramic Healing Caps, asserting its substantial equivalence to previously marketed predicate devices. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing efficacy against specific clinical outcomes. Therefore, the "acceptance criteria" and "device performance" in this context refer to engineering and biological performance characteristics compared against established standards for dental implant components.

Here's a breakdown of the requested information based on the provided text, noting where specific details are not available in a 510(k) summary:

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

Since this is a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with relevant international standards and equivalence to predicate devices. The "reported device performance" refers to the results of engineering and biocompatibility testing.

Acceptance Criteria Category	Specific Criteria / Standard Applied	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL): Minimum SAL of 10-6 per ISO 11135 (Ethylene Oxide sterilization).Endotoxin Limits: < 20 EU/device (based on FDA Guidance for blood-contacting/implanted devices).Packaging Integrity: Maintained after sterilization, handling, distribution, transport, and storage (demonstrated by ISTA 2A transportation study and packaging stability study).	Sterility Assurance Level (SAL): Validation performed per ISO 11135 demonstrating reliable and consistent sterilization to a minimum SAL of 10-6.Endotoxin Limits: LAL Endotoxin Analysis performed on finished packages from a production lot after sterilization demonstrated compliance with the < 20 EU/device limit.Packaging Integrity: A transportation study per ISTA 2A demonstrated integrity of the sterile barrier system. A packaging stability study demonstrated integrity of the packaging system and sterile barrier after all relevant processes and for the defined shelf life.
Biocompatibility	Biological safety assessed according to ISO 10993-1 guidelines.Cytotoxicity: Evaluated per ISO 10993-5.Chemical Characterization: Evaluated per ISO 10993-18.	Biological Safety: Assessed according to ISO 10993-1.Cytotoxicity: Tests performed per ISO 10993-5.Chemical Characterization: Tests performed per ISO 10993-18.(The document states these tests were performed, implying they met the acceptance criteria, but does not explicitly state the specific results or numerical compliance for each test. In a 510(k) summary, positive results are generally implied for substantial equivalence.)
Material Equivalence	The device's material properties (Y-TZP and titanium grade 4) and dimensions should be comparable to predicate devices to establish substantial equivalence.	The materials (Y-TZP and titanium grade 4) are consistent with materials used in the predicate and reference devices, or are well-established for this type of device. The technological characteristics table (Table 1) compares dimensions and materials, indicating fundamental similarity.

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

Sample Size for Test Set: The document does not specify exact sample sizes for the sterilization, endotoxin, packaging, or biocompatibility tests. It indicates that testing was performed on "production lot" or "completed package," which typically implies a statistically relevant sample size for validation, but the exact number isn't provided.
Data Provenance: Not specified. These are laboratory-based engineering and biological tests, not clinical studies involving human subjects or patient data. The manufacturer is Institut Straumann AG (based in Switzerland, submitted by Straumann USA, LLC), so the testing would likely have been conducted by them or a contract lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable for this type of submission. The "ground truth" for engineering and biocompatibility tests is based on established scientific principles and international standards (e.g., ISO, FDA guidance), not on expert consensus from clinical cases.

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

Not applicable. Adjudication methods are typically used in clinical studies when interpreting ambiguous patient data or images. The tests described are laboratory validations against objective criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for dental implants, not an AI/software device that involves human readers or image interpretation.

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

Not applicable. This is a physical medical device (healing caps), not an algorithm or software.

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

The "ground truth" for the performance data (sterilization, endotoxin, biocompatibility, packaging) is based on pre-defined specifications and international standards. For example, a sterility assurance level of 10-6 is a defined standard, not an expert consensus or pathology result. Endotoxin limits are also defined by regulatory guidance.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device. This term is relevant for machine learning or AI models.

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

Not applicable for the same reason as above.

Summary

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June 28, 2019

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K190654

Trade/Device Name: Straumann® CI RD Ceramic Healing Caps Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 31, 2019 Received: June 3, 2019

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 (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.

for

Srinivas Nandkumar, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K190654

Device Name

Straumann® CI RD Ceramic Healing Caps

Indications for Use (Describe)

Healing Caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.

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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Straumann® CI RD Ceramic Healing Caps

510(k) Summary

Submitter 1.1

Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Contact Person: Jennifer M. Jackson, MS - Director, Regulatory Affairs Phone Number: +1 (978) 747-2509 Fax Number: +1 (978) 747-0023 E-mail: jennifer.jackson@straumann.com Prepared By: Pierre-Yves Calinon - Regulatory Affairs & Compliance Manager Date of Submission: June 28, 2019

1.2 Device

Trade Name:	Straumann® CI RD Ceramic Healing Caps
Common Name:	Endosseous Dental Implant Abutment
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Regulatory Class:	II
Product Code:	NHA
Review Panel:	Dental

Predicate Device 1.3

Primary Predicate:	K180477 – Straumann PURE Ceramic Implant System
Reference Device:	K130808 – Straumann Healing Abutments, Healing Caps, Closure
Screws

Device Description 1.4

The Healing Caps are screws machined into 2 pieces and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is yttria-

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Straumann® CI RD Ceramic Healing Caps

510(k) Summary

stabilized tetragonal zirconia (Y-TZP) and titanium grade 4. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.

1.5 Indications for Use

Technological Characteristics 1.6

The proposed Straumann® CI RD Ceramic Healing Caps intended use and fundamental operating principals are identical to the primary predicated device, K180477. The additional components mentioned in the primary predicate device indications for use statement are not subject to this submission as the change only impacts the Healing Caps. The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1 below.

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Straumann® CI RD Ceramic Healing Caps

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
K Number andname of thedevice	K190654Straumann® CI RDCeramic Healing caps	K180477Straumann PURE CeramicImplants	K130808Straumann Sterile HealingSolution
Indications forUse	Healing Caps are intendedfor use with the StraumannDental Implant System(SDIS) to protect the innerconfiguration of the implantand maintain, stabilize andform the soft tissue duringthe healing process.Healing Caps should beused only with suitableimplant connections.The healing componentsare intended to be used upto 6 months.	Straumann PURE Ceramiclmplant:The Straumann PURE CeramicImplant is indicated for therestoration of single-tooth gaps andin edentulous or partially edentulousjaws. The prosthetic restorationsused are single crowns, fixed partialor full dentures, which areconnected to the implants throughthe corresponding components.Closure and healing caps:Closure and Healing caps areintended for use with theStraumann Dental Implant System(SDIS) to protect the innerconfiguration of the implant andmaintain, stabilize and form the softtissue during the healing process.Closure and Healing caps shouldbe used only with suitable implantconnections. Do not use healingcomponents for longer than 6months.Temporary Abutments:The provisional components areintended to serve as a base fortemporary crown or bridgerestoration out of occlusion for theStraumann® PURE Ceramic ImplantSystem. The Straumann®Temporary Abutment VITA CAD-Temp® for the Straumann® PURECeramic Implant is indicated fortemporary usage of up to 180 days.CI RD Straumann PUREbaseAbutments:CI RD Straumann PUREbaseabutment is a titanium base placedonto Straumann ceramic dentalimplants to provide support forcustomized prosthetic restorationsand is indicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridge restorations.All digitally designed copings and/orcrowns for use with the Straumann®Variobase Abutment system areintended to be sent to Straumannfor manufacture at a validatedmilling center.	Closure Screws, healingcaps, and healingabutments, are intended foruse with the StraumannDental Implant System(SDIS) to protect the innerconfiguration of the implantand maintain, stabilize andform the soft tissue duringthe healing process.Customizable healingabutments made of PEEKare for use up to six months.
Healing capmaterial	Y-TZP	Y-TZPClosure and Healing CapsTitanium Grade 4	Titanium Grade 4
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
K Number andname of thedevice	K190654Straumann® CI RDCeramic Healing caps	K180477Straumann PURE CeramicImplants	K130808Straumann Sterile HealingSolution
Implant to capconnection	Regular Diameter (RD)with a Y-TZP implantfixture and a Y-TZP cap/Tiscrew	RD with a Y-TZP implant fixture anda Ti cap/screw	Regular Neck (RN)/WideNeck (WN)/ Narrow NeckCrossFit (NNC)/ NarrowCrossFit (NC)/RegularCrossFit (RC) connectionswith Titanium-Zirconium(TiZr) or Ti implant fixtureand Ti cap/screw
Implant to capmode ofattachment	Screw retained	Screw retained	Screw retained
Diameter	Healing Cap:Ø5.2 mm	Closure Cap:Ø4.8 mmHealing Cap:Ø5.2 mm	Closure & Healing Caps:Ø3.5 mm – 6.5 mm
Overall height	Healing Cap:6.2, 7.2, and 8.7 mm	Closure Cap:4.6 mmHealing Cap:6.2 and 7.2 mm	Closure Cap:6.2 and 6.8 mmHealing Cap:8.1, 9.6, and 11.1 mm
Gingival height	Healing Cap:2.0, 3.0, and 4.5 mm	Closure Cap:0.5 mmHealing Cap:2.0 and 3.0 mm	Closure Cap:0 mm and 0.5 mmHealing Cap:2.0, 3.0, and 4.5 mm
Sterilizationmethod	End user receives productsterilized per Ethyleneoxide to an SAL of 10-6	Straumann PURE CeramicImplantsEthylene oxide to an SAL of 10-6Closure and Healing CapsEnd user receives product sterilizedper Irradiation to an SAL of 10-6	End user receives productsterilized per Irradiation toan SAL of 10-6

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Straumann® CI RD Ceramic Healing Caps

510(k) Summary

Table 1 – Comparison of Subject Device with Primary Predicate and Reference Devices

Performance Data 1.7

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

Sterilization

A sterilization validation was performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.

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Straumann® CI RD Ceramic Healing Caps

510(k) Summary

The method used to make the determination that the device meets endotoxin limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device. The testing limit was chosen based on a device that is blood contacting and/or implanted, as outlined in the FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016. In all cases, the testing was performed on the completed package from a production lot after sterilization.

A transportation study has been performed per ISTA 2A to demonstrate the integrity of the sterile barrier system considering the new sterilization process.

A packaging stability study was performed to demonstrate the integrity of the packaging system and the sterile barrier system after sterilization process via Ethylene Oxide, handling, distribution, transport and storage up to the defined product shelf life.

Biocompatibility Testing

The biological safety of the CI RD Ceramic Healinq caps was assessed according to the ISO 10993-1 and tests were conducted to assess the following:

Cytotoxicity (ISO 10993-5) ●
Chemical Characterization (ISO 10993-18) .

1.8 Conclusion

Based upon assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate and/or 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.)