(84 days)
No
The summary describes a physical dental healing abutment and its intended use, device description, and performance studies, none of which mention AI or ML.
No.
The device description indicates its purpose is to protect the inner configuration of the implant, stabilize and form soft tissue during healing, and not to support a prosthetic restoration, which are structural and protective functions, not therapeutic in nature.
No
Explanation: The device description clearly states that Straumann® Ceramic Healing abutments are used to protect the inner configuration of an implant, maintain soft tissue, and aid in the healing process. They are not mentioned to be used for diagnostic purposes like identifying, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a two-piece physical device made of ceramic and a basal screw, intended for placement in the patient's mouth.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Straumann® Ceramic Healing abutments are physical devices placed in the patient's mouth to aid in the healing process after implant placement. They do not analyze any biological samples.
- Intended Use: The intended use clearly describes a mechanical function within the body (protecting the implant, maintaining soft tissue) rather than an analytical function on a sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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)
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
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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.