Who is the manufacturer of Straumann Ceramic Healing Abutments?

Institut Straumann AG filed the 510(k) submission for Straumann Ceramic Healing Abutments (K192893).

What is the FDA product code for Straumann Ceramic Healing Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann Ceramic Healing Abutments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Straumann Ceramic Healing Abutments?

Straumann PURE Ceramic Healing caps (K190654).

Who can help prepare an FDA 510(k) submission like Straumann Ceramic Healing Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann Ceramic Healing Abutments

K192893 · Institut Straumann AG · NHA · Jan 3, 2020 · Dental

Device Facts

Record ID	K192893
Device Name	Straumann Ceramic Healing Abutments
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Jan 3, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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.

Device Story

Two-piece ceramic healing abutments; feature ceramic ring in various heights with preassembled TAN (Ti-6Al-7Nb) basal screw. Screwed into dental implants during transmucosal healing protocols; protect inner implant configuration; maintain/stabilize soft tissue. Placed out of occlusion; do not support prosthetic restoration. Used in dental clinics by dentists/oral surgeons. Benefits patient by facilitating proper soft tissue healing around implant site. Device is temporary, used for up to 6 months.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1, -5, -12, -17, and -18. Sterilization validated per ISO 11135 (Half Cycle Overkill Approach) to SAL 10^-6. Endotoxin levels verified via LAL analysis (limit 20 EU/device).

Technological Characteristics

Materials: Y-TZP (ceramic) and Ti-6Al-7Nb (TAN) screw. Dimensions: NC (Ø3.6/4.8mm) and RC (Ø4.5-6.5mm) diameters; 8-12mm lengths. Connection: CrossFit® (NC/RC). Sterilization: Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for placement in the patient's mouth at the end of implant placement to protect the inner configuration of the implant and maintain, stabilize, and form soft tissue during the healing process. For use with suitable implant connections for up to 6 months.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Straumann PURE Ceramic Healing caps (K190654)

Reference Devices

Small Diameter Implant (SDI) (K162890)
MRI compatibility for existing Straumann dental implant systems (K190662)

Related Devices

K212730 — BellaTek Encode Emergence Healing Abutments · Biomet 3i, LLC · Dec 21, 2021
K072679 — P.004 ABUTMENTS · Institut Straumann AG · Oct 12, 2007
K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) · Straumann Manufacturing, Inc. · Sep 20, 2007
K960634 — TITANIUM HEALING CAPS · The Straumann Co. · Jun 18, 1996
K190654 — Straumann CI RD Ceramic Healing Caps · Institut Straumann AG · Jun 28, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 3, 2020 Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K192893 Trade/Device Name: Straumann® Ceramic Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 10, 2019 Received: October 11, 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. {1}------------------------------------------------ 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. 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 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K192893 Device Name: Straumann® Ceramic Healing Abutments #### Indications for Use (Describe) Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) {3}------------------------------------------------ # K192893 – Traditional 510(k) ## Straumann® Ceramic Healing Abutments 510(k) Summary #### 510(k) Summary 5 #### 5.1 Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Institut Straumann AG Peter Merian Weg, 12 CH-4002 Basel, Switzerland | | Contact Person: | Jennifer M. Jackson, MS Director Regulatory Affairs Phone Number: +1 978 747 2509 Fax Number: +1 978 747 0023 | | Prepared By & Alternate Contact: | Laure Kuhner Borsenberger Regulatory Affairs Specialist Institut Straumann AG Phone number : +41 61 965 13 89 | | Date Prepared: | January 2, 2020 | ## 5.2 Name of the Device | Trade Names: | Straumann® Ceramic Healing Abutments | |------------------------|--------------------------------------| | Common Name: | Endosseous Dental Implant Abutment | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | §872.3630 | | Device Classification: | II | | Product Codes(s): | NHA | | Classification Panel: | Dental | {4}------------------------------------------------ ## K192893 - Traditional 510(k) ## Straumann® Ceramic Healing Abutments 510(k) Summary ## 5.3 Predicate Device(s) Primary Predicate: - . K190654 - Straumann PURE Ceramic Healing caps Reference Devices: - K162890 Small Diameter Implant (SDI) . - . K 190662 - MRI compatibility for existing Straumann dental implant systems ### 5.4 Device Description Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. The Ceramic Healing Abutments are two-piece devices that feature a ceramic ring in various heights to accommodate individual gingival thickness, with a preassembled TAN basal screw. The pre-assembled TAN basal screw is fixed into the ceramic ring and cannot be removed. ### 5.5 Intended Use 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. ### 5.6 Indications for Use Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. The healing components are intended to be used up to 6 months. #### Technological Characteristics 5.7 The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. For clarity in comparison to the reference device K162890, only the relevant part of the indications for use is included in the {5}------------------------------------------------ # K192893 – Traditional 510(k) ## Straumann® Ceramic Healing Abutments 510(k) Summary comparison table. The reference predicate K190662 is included for reference to MRI compatibility only and is not included in the comparison table below. | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | | K190654 | K162890 | | Indications for Use | Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. The healing components are intended to be used up to 6 months. | 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® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. | | Material | Y-TZP Ti-6Al-7Nb or TAN (screw) | Y-TZP Titanium Grade 4 (screw) | Titanium Grade 4 Ti-6Al-7Nb or TAN (screw) | | Implant to Abutment Connection | Narrow CrossFit® (NC) Regular CrossFit® (RC) | Regular Diameter (RD) | Small CrossFit® (SC) | | Diameter or Minor Oval Dimension/ Major Oval Dimension | NC: Ø3.6 & 4.8 mm RC: Ø4.5, 5.0, 6.0, and 6.5 mm | Ø5.2 mm | Closure Cap: Ø2.4 mm Healing Abutments: Ø3.3/4.3 mm Ø3.55/4.86 mm Ø3.6/5.0 mm | | Overall Length | NC: 8 to 11 mm RC: 8 to 12 mm | 6.2 to 8.7 mm | Closure Cap: 5.8 mm Healing Abutment: 7.0 to 11.5 mm | | Gingival Heights | NC: 2.0, 3.5, and 5.0 mm RC: 2.0, 4.0, and 6.0 mm | 2.0, 3.0, and 4.5 mm | Closure Cap: 0.5 mm Healing Abutments: 2.0, 3.5, 5.0, and 6.5 mm | Table 1 – Comparison of subject device versus primary predicate and reference devices {6}------------------------------------------------ # K192893 – Traditional 510(k) ## Straumann® Ceramic Healing Abutments 510(k) Summary #### 5.8 Performance Testing The subject devices were evaluated for biocompatibility according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and 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". Although the subject device materials are identical to the primary predicate and reference device materials, cytotoxicity and chemical characterization tests were performed due to differences in the manufacturing process. These tests were conducted according to ISO 10993-5, 10993-12, 10993-17 and 10993-18. 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. 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. #### 5.9 Conclusion The documentation submitted in this premarket notification demonstrates the Straumann® Ceramic Healing Abutments are substantially equivalent to the primary predicate and reference devices.