(87 days)
No
The summary describes a pre-milled dental abutment that is customized using CAD/CAM technology. There is no mention of AI or ML in the intended use, device description, or performance studies. The customization process appears to be based on traditional CAD/CAM methods, not AI/ML algorithms.
Yes.
The device is a pre-milled abutment used as a support for dental prostheses to restore chewing function in patients with missing teeth, which clearly indicates a therapeutic purpose.
No
This device is a pre-milled abutment used as a support for dental prostheses, not for diagnosing conditions.
No
The device is a physical dental abutment made of Ti-6AI-4V-ELI, which is a hardware component. While CAD/CAM technology is used in its customization, the device itself is not software only.
Based on the provided text, the LW Pre-milled Abutment is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: 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.
- Intended Use: The intended use of the LW Pre-milled Abutment is to support dental prostheses in the mouth of a patient. This is a direct interaction with the patient's body for a restorative purpose, not for analyzing a specimen outside the body.
- Device Description: The description details the material, manufacturing process, and how it's used in conjunction with dental implants and prostheses. There is no mention of analyzing biological samples.
- Lack of IVD-related information: The text does not include any information typically associated with IVD devices, such as:
- Analysis of biological specimens.
- Diagnostic claims.
- Performance metrics like sensitivity, specificity, etc., which are relevant to diagnostic accuracy.
The LW Pre-milled Abutment is a dental prosthetic device intended for surgical implantation and subsequent use in supporting dental restorations.
N/A
Intended Use / Indications for Use
LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Compatible Implant | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| LW Implant | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 |
| LW Narrow Implant | 3.75/3.77 | 3.75/3.77 |
LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The LW Pre-milled Abutment is made of Ti-6AI-4V-ELI (ASTM F136), and it is provided non-sterile, which is required to be sterilized by the end-user before use. The subject abutment is indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations.
To produce patient-specific abutments, the cylindrical section of LW Pre-milled Abutment is customized by machining it using CAD/CAM technology. Each patient-specific abutment is custom-prescribed by the clinician.
| Abutment Name | Uses | Surface Treatment | Fixture Connection |
|---|---|---|---|
| LW Pre-milled Abutment | The Abutment is used as a support of prosthesis to restore the patient's chewing function. | N/A | Hex 2.48 / Non-Hex |
| LW Narrow Pre-milled Abutment | N/A | Hex 2.08 / Non-Hex |
LW Pre-milled Abutment is compatible with following Implant System.
-
LW Pre-milled Abutment
Proprietary Name: LW Implant System
Pre-market Submission Number: K223924
Compatible Implant Device Name: LW Implant
Implant Interface Connection Type/Size (mm): Internal Connection Type/2.5
Type of Implant-Abutment Connection: Hex/Non-Hex
LW Pre-milled Abutment is used with an LW Abutment Screw in LW Implant System(K223924). -
LW Narrow Pre-milled Abutment
Proprietary Name: LW Narrow Implant System
Pre-market Submission Number: K233808
Compatible Implant Device Name: LW Narrow Implant
Implant Interface Connection Type/Size (mm): Internal Connection Type/2.1
Type of Implant-Abutment Connection: Hex/Non-Hex
LW Narrow Pre-milled Abutment is used with an LW Narrow Abutment Screw in LW Narrow Implant System(K233808).
The design envelope for Patient-Specific Abutment are as follows:
| LW Pre-milled Abutment (Internal Connection 2.5) | LW Narrow Pre-milled Abutment (Internal Connection 2.1) | |
|---|---|---|
| Diameter | 4.5-7.0 mm | 4.0, 4.5 mm |
| Length | Straight: 7.9 - 16.9 mm Angled: 12.9, 14.9 mm | |
| Minimum gingival height | 1.0 mm | |
| Maximum gingival height | 7.0 mm | |
| Minimum wall thickness | 0.4 mm | |
| Minimum post height for single-unit restorations (length above the abutment collar / gingival height) | 4.0 mm | |
| Maximum angulation | 30° |
Materials:
- LW Pre-milled Abutment is fabricated from Ti-6Al-4V of ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
Non-Clinical Test Data:
- End User Sterilization Validation Test according to ISO 17665-1.-2. The recommended sterilization conditions have been validated following ISO 17665-1, ISO 17665-2, and the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The validation considered the worst-case scenario, and the results demonstrated equivalence to the predicate device.
- Fatigue Testing according to ISO 14801:2016 referenced in K233808 and K233167. Dynamic Fatigue and Static Compression Strength tests were conducted according to the FDA guidance document 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments' and ISO 14801:2016 'Dentistry – Implants – Dynamic fatigue test for endosseous dental implants' under the worst-case scenario.
- Biocompatibility Testing on Abutments according to ISO 10993-1: 2018 referenced in K223924. Biocompatibility Testing was performed in accordance with ISO 10993-1 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".
- MRI Safety: Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Key results: The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices. The compatibility and performance of the device have been demonstrated through fatigue testing.
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.
K203344, K223924, K233167, K233808
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ossvis Co., Ltd. % April Lee Consultant Withus Group, Inc. 106 Superior Irvine, California 92620
December 5, 2024
Re: K242703
Trade/Device Name: LW Pre-milled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 6, 2024 Received: September 9, 2024
Dear April Lee:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known)
K242703 | |
| Device Name
LW Pre-milled Abutment | |
Indications for Use (Describe)
LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| No. | Compatible Implant | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| 1 | LW Implant | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/ | |
| 5.45/5.9/5.95/6.55/6.6/6.8/6.85/ | |||
| 7.25/7.3/7.35/7.75/7.8/7.85 | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/ | ||
| 5.45/5.9/5.95/6.55/6.6/6.8/6.85/ | |||
| 7.25/7.3/7.35/7.75/7.8/7.85 | |||
| 2 | LW Narrow Implant | 3.75/3.77 | 3.75/3.77 |
LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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4
510(K) Summary
Submitter
Ossvis Co., Ltd. Woo Jin Lee 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea Email: wjl316@ossvis.com Tel. +82-31-360-0082 Fax. +82-31-360-0058
Device Information
- Trade Name: LW Pre-milled Abutment ●
- Common Name: Endosseous dental implant abutment
- Classification Name: Abutment, Implant, Dental, Endosseous ●
- Product Code: NHA ●
- Panel: Dental
- Regulation Number: 21 CFR 872.3630 ●
- Device Class: Class II
- Date Prepared: 11/29/2024
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K210362, s-Clean Pre-Milled Abutment by Dentis Co., Ltd.
Reference Device
- K203344, Premilled Titanium Block System by InnoBioSurg Co., Ltd. ●
- K223924, LW Implant System by Ossvis Co., Ltd.
- K233167, LW Implant System Abutment by Ossvis Co., Ltd. ●
- K233808, LW Narrow Implant System by Ossvis Co., Ltd. ●
Indication for Use:
LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| No. | Compatible Implant | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| 1 | LW Implant | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/ | |
| 5.45/5.9/5.95/6.55/6.6/6.8/6.85/ | |||
| 7.25/7.3/7.35/7.75/7.8/7.85 | 4.2/4.55/4.6/5.0/5.05/5.07/5.4/ | ||
| 5.45/5.9/5.95/6.55/6.6/6.8/6.85/ | |||
| 7.25/7.3/7.35/7.75/7.8/7.85 | |||
| 2 | LW Narrow Implant | 3.75/3.77 | 3.75/3.77 |
LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
5
Device Description:
The LW Pre-milled Abutment is made of Ti-6AI-4V-ELI (ASTM F136), and it is provided non-sterile, which is required to be sterilized by the end-user before use. The subject abutment is indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations.
To produce patient-specific abutments, the cvlindrical section of LW Pre-milled Abutment is customized by machining it using CAD/CAM technology. Each patient-specific abutment is custom-prescribed by the clinician.
| Abutment Name | Uses | Surface
Treatment | Fixture Connection |
|-------------------------------|--------------------------------------------------------------------------------------------------|----------------------|--------------------|
| LW Pre-milled Abutment | The Abutment is used as a support
of prosthesis to restore the patient's
chewing function. | N/A | Hex 2.48 / Non-Hex |
| LW Narrow Pre-milled Abutment | | N/A | Hex 2.08 / Non-Hex |
LW Pre-milled Abutment is compatible with following Implant System.
1) LW Pre-milled Abutment
| Proprietary Name | LW Implant System |
|---|---|
| Pre-market Submission Number | K223924 |
| Compatible Implant Device Name | LW Implant |
| Implant Interface Connection Type/Size (mm) | Internal Connection Type/2.5 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
LW Pre-milled Abutment is used with an LW Abutment Screw in LW Implant System(K223924).
2) LW Narrow Pre-milled Abutment
| Proprietary Name | LW Narrow Implant System |
|---|---|
| Pre-market Submission Number | K233808 |
| Compatible Implant Device Name | LW Narrow Implant |
| Implant Interface Connection Type/Size (mm) | Internal Connection Type/2.1 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
LW Narrow Pre-milled Abutment is used with an LW Narrow Abutment Screw in LW Narrow Implant System(K233808).
The design envelope for Patient-Specific Abutment are as follows:
| | LW Pre-milled Abutment
(Internal Connection 2.5) | LW Narrow Pre-milled Abutment
(Internal Connection 2.1) |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------|
| Diameter | 4.5-7.0 mm | 4.0, 4.5 mm |
| Length | Straight: 7.9 - 16.9 mm
Angled: 12.9, 14.9 mm | |
| Minimum gingival height | 1.0 mm | |
| Maximum gingival height | 7.0 mm | |
| Minimum wall thickness | 0.4 mm | |
| Minimum post height for single-unit
restorations (length above the
abutment collar / gingival height) | 4.0 mm | |
| Maximum angulation | 30° | |
Materials:
- LW Pre-milled Abutment is fabricated from Ti-6Al-4V of ASTM F136 .
6
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| Subject Device | Primary Predicate | Reference Device | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) # | K242703 | K210362 | K203344 | |||||||||||||||||||||||||||||||||||||||
| Device | ||||||||||||||||||||||||||||||||||||||||||
| Name | LW Pre-milled Abutment | s-Clean Pre-Milled Abutment | Premilled Titanium Block System | |||||||||||||||||||||||||||||||||||||||
| Manufacture | ||||||||||||||||||||||||||||||||||||||||||
| r | Ossvis Co., Ltd. | Dentis Co., Ltd. | InnoBioSurg Co., Ltd. | |||||||||||||||||||||||||||||||||||||||
| Product | ||||||||||||||||||||||||||||||||||||||||||
| Code | NHA | NHA | NHA | |||||||||||||||||||||||||||||||||||||||
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | |||||||||||||||||||||||||||||||||||||||
| Indications | ||||||||||||||||||||||||||||||||||||||||||
| for Use | ||||||||||||||||||||||||||||||||||||||||||
| Statement | LW Pre-milled Abutment is intended for use with | |||||||||||||||||||||||||||||||||||||||||
| dental implants as a support for single or multiple | ||||||||||||||||||||||||||||||||||||||||||
| tooth prostheses in the maxilla or mandible of a | ||||||||||||||||||||||||||||||||||||||||||
| partially or fully edentulous patient. | ||||||||||||||||||||||||||||||||||||||||||
| Compatible | ||||||||||||||||||||||||||||||||||||||||||
| Implant Implant | ||||||||||||||||||||||||||||||||||||||||||
| Diameter | ||||||||||||||||||||||||||||||||||||||||||
| (mm) Platform | ||||||||||||||||||||||||||||||||||||||||||
| Diameter (mm) LW Implant Ø4.2/4.55/ | ||||||||||||||||||||||||||||||||||||||||||
| 4.6/5.0/5.05/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.07/5.4/5.45 | ||||||||||||||||||||||||||||||||||||||||||
| /5.9/5.95/6.55 | ||||||||||||||||||||||||||||||||||||||||||
| /6.6/6.8/6.85/ | ||||||||||||||||||||||||||||||||||||||||||
| 7.25/7.3/7.35 | ||||||||||||||||||||||||||||||||||||||||||
| /7.75/7.8/7.85 Ø4.2/4.55/ | ||||||||||||||||||||||||||||||||||||||||||
| 4.6/5.0/5.05/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.07/5.4/5.45 | ||||||||||||||||||||||||||||||||||||||||||
| /5.9/5.95/6.55 | ||||||||||||||||||||||||||||||||||||||||||
| /6.6/6.8/6.85/ | ||||||||||||||||||||||||||||||||||||||||||
| 7.25/7.3/7.35 | ||||||||||||||||||||||||||||||||||||||||||
| /7.75/7.8/7.85 LW Narrow | ||||||||||||||||||||||||||||||||||||||||||
| Implant Ø3.75/3.77 Ø3.75/3.77 LW Pre-milled Abutment is intended for use the | ||||||||||||||||||||||||||||||||||||||||||
| LW Implant System in the chart. All digitally | ||||||||||||||||||||||||||||||||||||||||||
| designed abutments for use with LW Pre-milled | ||||||||||||||||||||||||||||||||||||||||||
| Abutment are intended to be manufactured at the | ||||||||||||||||||||||||||||||||||||||||||
| OSSVIS-validated milling center. | s-Clean Pre-Milled Abutment is intended for use | |||||||||||||||||||||||||||||||||||||||||
| with dental implants as a support for single or | ||||||||||||||||||||||||||||||||||||||||||
| multiple tooth prostheses in the maxilla or | ||||||||||||||||||||||||||||||||||||||||||
| mandible of a partially or fully edentulous patient. Implant System | ||||||||||||||||||||||||||||||||||||||||||
| Compatibility Implant | ||||||||||||||||||||||||||||||||||||||||||
| Diameter | ||||||||||||||||||||||||||||||||||||||||||
| (mm) Platform | ||||||||||||||||||||||||||||||||||||||||||
| Diameter | ||||||||||||||||||||||||||||||||||||||||||
| (mm) s-Clean SQ-SL Fixture Ø5.8 | ||||||||||||||||||||||||||||||||||||||||||
| Ø6.8 Ø4.3 | ||||||||||||||||||||||||||||||||||||||||||
| Ø4.5 s-Clean Pre-Milled Abutment is intended for use | ||||||||||||||||||||||||||||||||||||||||||
| with the s-Clean SQ-SL Fixtures in the chart. All | ||||||||||||||||||||||||||||||||||||||||||
| digitally designed abutments for use with s-Clean | ||||||||||||||||||||||||||||||||||||||||||
| Pre-Milled Abutment are intended to be | ||||||||||||||||||||||||||||||||||||||||||
| manufactured at a Dentis validated milling center. | Premilled Titanium Block System is intended for | |||||||||||||||||||||||||||||||||||||||||
| use with dental implants as a support for single or | ||||||||||||||||||||||||||||||||||||||||||
| multiple tooth | ||||||||||||||||||||||||||||||||||||||||||
| prostheses in the maxilla or mandible of a | ||||||||||||||||||||||||||||||||||||||||||
| partially or fully edentulous patient. Implant System | ||||||||||||||||||||||||||||||||||||||||||
| Compatibility Implant | ||||||||||||||||||||||||||||||||||||||||||
| Diameter | ||||||||||||||||||||||||||||||||||||||||||
| (mm) Platform | ||||||||||||||||||||||||||||||||||||||||||
| Diameter | ||||||||||||||||||||||||||||||||||||||||||
| (mm) IBS Implant System 3.8/4.3/4.8/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.3/5.8/6.3 3.8/4.3/4.8/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.3/5.8/6.3 IBS Implant System 3.5/4.0/4.5/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.0/5.5/6.0/6.5 3.5/4.0/4.5/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.0/5.5/6.0/6.5 Magicore System 4.0/4.5/5.0/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.5/6.0/6.5 4.0/4.5/5.0/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.5/6.0/6.5 IBS Implant System II 3.5/3.8/4.0/4.5/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.0/5.5/6.0/6.5 3.5/3.8/4.0/4.5/ | ||||||||||||||||||||||||||||||||||||||||||
| 5.0/5.5/6.0/6.5 Premilled Titanium Block System is intended for | ||||||||||||||||||||||||||||||||||||||||||
| use with the IBS implant system, Magicore | ||||||||||||||||||||||||||||||||||||||||||
| System and IBS Implant System II in the chart. | ||||||||||||||||||||||||||||||||||||||||||
| All digitally designed abutments for use with | ||||||||||||||||||||||||||||||||||||||||||
| Premilled Titanium Block System are intended to | ||||||||||||||||||||||||||||||||||||||||||
| be manufactured at a Innobiosurg validated | ||||||||||||||||||||||||||||||||||||||||||
| milling center. | ||||||||||||||||||||||||||||||||||||||||||
| Gingival | ||||||||||||||||||||||||||||||||||||||||||
| Height (mm) | Min 1.0 / Max 7.0 | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | Not identified | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | Min 0.5 / Max 7.0 | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | ||||||||||||||||||||||||||||||||||||||||||
| Post Height | ||||||||||||||||||||||||||||||||||||||||||
| (mm) | Min 4.0 | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | Not identified | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | Min 4.0 | |||||||||||||||||||||||||||||||||||||||||
| (Patient-specific milling design envelope) | ||||||||||||||||||||||||||||||||||||||||||
| Connection | ||||||||||||||||||||||||||||||||||||||||||
| Type | Hex, Non-Hex | Hex, Non-Hex | Hex, Non-Hex |
7
| Type of
| Retention | Screw-retained or cement retained | Screw-retained or cement retained | Screw-retained or cement retained |
|---|---|---|---|
| Anatomical | |||
| Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) |
| Surface | |||
| treatment | N/A | N/A | N/A |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalence Discussion |
The subject device is substantially equivalent of the (K210362) in terms of indications for use, material, surface treatment, sterlizzation, and design. Although there are differences in dimensions and compatible intended use or affect the safety and performance of the device. The subject device is designed, manufactured with the FDA's Class II special controls guidance document root-food ental implants and endosseous dental implant abutnent . The impatibility and performance of the device have been demonstrated through fairgue testing. Additionally, we included the reference device (K20334) to support the reference device has the same intensed use, which is to support the prosthesis in order to restore the patient s cheving for the subject to the subject device in terms of design and manufacturing characteristics. Therefore, we believe that the subject device is substantially equivalent to the predicate device.
8
Non-Clinical Test Data
Below tests were performed on the subject device:
-
. End User Sterilization Validation Test according to ISO 17665-1.-2
In this submission, we leverage our previous 510(k) submission data for the below test data: -
Fatigue Testing according to ISO 14801:2016 referenced in K233808 and K233167 ●
-
Biocompatibility Testing on Abutments according to ISO 10993-1: 2018 referenced in K223924 .
End User Sterilization Validation
The non-sterile abutments are intended to be sterilized by the end user. The recommended sterilization conditions have been validated through the end-user sterilization, following ISO 17665-1 "Sterilization of health care products – Moist heat – part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterilization of health care products – Moist heat – part 2: Guidance on the application of ISO 17665-1", and the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The validation considered the worst-case scenario, and the results demonstrated equivalence to the predicate device.
Biocompatibility Tests
Biocompatibility Testing was performed in accordance with ISO 10993-1 "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".
Fatigue Test
To evaluate the performance of subject devices, Dynamic Fatigue and Static Compression Strength tests were conducted according to the FDA guidance document titled 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments' and ISO 14801:2016 'Dentistry – Implants – Dynamic fatigue test for endosseous dental implants' under the worst-case scenario.
MRI Safety
Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. " Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795). Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices.
Conclusion
The documentation submitted in this premarket notification demonstrates the LW Pre-milled Abutment is substantially equivalent to the primary predicate device.