K Number

Device Name

Straumann CI RD Ceramic Healing Caps

Manufacturer

Institut Straumann AG

Date Cleared

2019-06-28

(106 days)

Product Code

NHA

Regulation Number

872.3630

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180477

Reference Devices

K130808

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (healing caps) made of zirconia and titanium, with no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on sterilization, endotoxin levels, transportation, packaging, and biocompatibility, which are standard for medical devices and do not indicate AI/ML involvement.

Therapeutic

No
The device is described as a "Healing Cap" intended for use with dental implants to protect the inner configuration of the implant and manage soft tissue during the healing process, not to treat a disease or condition itself. It aids the healing process but does not directly provide therapy.

Diagnostic

No
Healing Caps are described as devices that protect the inner configuration of the implant and maintain, stabilize, and form soft tissue during the healing process. There is no mention of them being used to diagnose any condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly states the device is made of physical materials (yttria-stabilized tetragonal zirconia and titanium grade 4) and is a screw machined into two pieces, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the Healing Caps are used with a dental implant system to protect the implant and manage soft tissue during the healing process. This is a direct interaction with the patient's body for a therapeutic purpose (facilitating healing).
Device Description: The description details a physical screw made of specific materials that is placed into the implant.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body as part of a surgical and healing process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NHA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Sterilization: A sterilization validation was performed per ISO 11135, 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. The method used to determine that the device meets endotoxin limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.
Transportation Study: A transportation study has been performed per ISTA 2A to demonstrate the integrity of the sterile barrier system considering the new sterilization process.
Packaging Stability Study: 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 Healing caps was assessed according to the ISO 10993-1 and tests were conducted to assess Cytotoxicity (ISO 10993-5) and Chemical Characterization (ISO 10993-18).

Key Metrics

Not Found

Predicate Device(s)

K180477

Reference Device(s)

K130808

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.)

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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.

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

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-

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.

Straumann® CI RD Ceramic Healing Caps

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
K Number and
name of the
device	K190654
Straumann® CI RD
Ceramic Healing caps	K180477
Straumann PURE Ceramic
Implants	K130808
Straumann Sterile Healing
Solution
Indications for
Use	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.	Straumann PURE Ceramic
lmplant:
The Straumann PURE Ceramic
Implant is indicated for the
restoration of single-tooth gaps and
in edentulous or partially edentulous
jaws. The prosthetic restorations
used are single crowns, fixed partial
or full dentures, which are
connected to the implants through
the corresponding components.
Closure and healing caps:
Closure and 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.
Closure and Healing caps should
be used only with suitable implant
connections. Do not use healing
components for longer than 6
months.
Temporary Abutments:
The provisional components are
intended to serve as a base for
temporary crown or bridge
restoration out of occlusion for the
Straumann® PURE Ceramic Implant
System. The Straumann®
Temporary Abutment VITA CAD-
Temp® for the Straumann® PURE
Ceramic Implant is indicated for
temporary usage of up to 180 days.
CI RD Straumann PUREbase
Abutments:
CI RD Straumann PUREbase
abutment is a titanium base placed
onto Straumann ceramic dental
implants to provide support for
customized prosthetic restorations
and is 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 Abutment system are
intended to be sent to Straumann
for manufacture at a validated
milling center.	Closure Screws, healing
caps, and healing
abutments, 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.
Customizable healing
abutments made of PEEK
are for use up to six months.
Healing cap
material	Y-TZP	Y-TZP
Closure and Healing Caps
Titanium Grade 4	Titanium Grade 4
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
K Number and
name of the
device	K190654
Straumann® CI RD
Ceramic Healing caps	K180477
Straumann PURE Ceramic
Implants	K130808
Straumann Sterile Healing
Solution
Implant to cap
connection	Regular Diameter (RD)
with a Y-TZP implant
fixture and a Y-TZP cap/Ti
screw	RD with a Y-TZP implant fixture and
a Ti cap/screw	Regular Neck (RN)/Wide
Neck (WN)/ Narrow Neck
CrossFit (NNC)/ Narrow
CrossFit (NC)/Regular
CrossFit (RC) connections
with Titanium-Zirconium
(TiZr) or Ti implant fixture
and Ti cap/screw
Implant to cap
mode of
attachment	Screw retained	Screw retained	Screw retained
Diameter	Healing Cap:
Ø5.2 mm	Closure Cap:
Ø4.8 mm
Healing 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 mm
Healing Cap:
6.2 and 7.2 mm	Closure Cap:
6.2 and 6.8 mm
Healing 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 mm
Healing Cap:
2.0 and 3.0 mm	Closure Cap:
0 mm and 0.5 mm
Healing Cap:
2.0, 3.0, and 4.5 mm
Sterilization
method	End user receives product
sterilized per Ethylene
oxide to an SAL of 10-6	Straumann PURE Ceramic
Implants
Ethylene oxide to an SAL of 10-6
Closure and Healing Caps
End user receives product sterilized
per Irradiation to an SAL of 10-6	End user receives product
sterilized per Irradiation to
an SAL of 10-6

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.

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.