(125 days)
No
The document describes a physical dental abutment and its manufacturing process using CAD/CAM software, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device itself. The software mentioned (DWOS or 3Shape) is standard CAD/CAM software for dental prosthetics, not explicitly AI/ML-driven.
No
The device is a component of a dental implant system used to support prosthetic restorations, not to treat a disease or condition. While it aids in restoring function, it doesn't have a therapeutic effect itself.
No
Explanation: The device is a prosthetic component (titanium base abutment) used to support dental restorations. Its intended use and description focus on mechanical support and fabrication of prosthetics, not on detecting, diagnosing, treating, or preventing disease.
No
The device description clearly states it is a physical titanium base abutment and a two-piece abutment system, not solely software. While it mentions the use of CAD/CAM software for design, the device itself is a manufactured hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Titanium Base Abutment and GM Titanium Base for Bridge are prosthetic components installed onto dental implants to support final prostheses (crowns, bridges). They are physical devices used within the body, not for testing samples outside the body.
- Intended Use: The intended use is to provide support for dental restorations, which is a structural and mechanical function, not a diagnostic one.
- Lack of Diagnostic Information: The text does not mention any analysis of biological samples or the generation of diagnostic information about a patient's health condition.
Therefore, this device falls under the category of a dental prosthetic component, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The GM Titanium Base for Bridge are prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Titanium Base for Bridge is a two-piece abutment used as a base when fabricating a CAD/CAM customized restoration. The planning and milling of the customized superstructures should be made using the validated Dental Wings Operating System (DWOS) or 3Shape Software. All digitally designed copings and/or crowns for use with the GM Titanium Base for Bridge are intended to be manufactured as a validated milling center. The limits for customization are stated in the GM Titanium Base for Bridge Instructions for Use. The superstructure produced through the CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Titanium Base for Bridge.
The main characteristics of the subject devices are the following:
- Intended for single use;
- Provided sterile via ethylene oxide gas;
- Manufactured of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
- Conical format available in different diameters, height of cementable area and gingival height;
- Screw-retained;
- Provided in rotational (non-indexed) version supporting multi-unit restorations;
- Provided with an implant-to-abutment interface compatible with the GM implants of the Neodent Implant System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Titanium Base for Bridge, according to FDA Guidance. The abutments were tested with three different restoration materials and all of them are in accordance with the acceptance criteria.
Torsion testing was performed to evaluate the Titanium Base Screws under static torsional loading. The results met the acceptance criteria.
Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 10th has been validated.
Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Biological Safety Assessment guided by ISO 10993-1.
Cytotoxicity testing was performed per ISO 10993-5.
Chemical characterization was performed per ISO 10993-18.
Biocompatibility sample preparation was performed per ISO 10993-12.
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.
K180536, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A
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 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
December 19, 2019
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, INC. 60 Minuteman Road Andover, Massachusetts 01810
Re: K192229
Trade/Device Name: Neodent Implant System - GM Titanium Base for Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 22, 2019 Received: November 25, 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.
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192229
Device Name
Neodent Implant System - GM Titanium Base for Bridge
Indications for Use (Describe)
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.
| 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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3
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(dba Neodent)
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Parana, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS
Director of Regulatory Affairs,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 09/Dec/2019 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
E-mail: mariana.hartmann@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Neodent Implant System – GM Titanium Base for Bridge
Endosseous dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations
Product Code | 21 CFR 872.3630, Class II
NHA |
| Classification Panel
Reviewing Branch | Dental Products Panel
Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K180536, Neodent Implant System - GM Line, JJGC Indústria e
Comércio de Materiais Dentários S.A |
| Reference Predicate Devices | K151157 - NC Straumann Variobase Abutment For Bars/Bridges,
RC Straumann Variobase Abutment For Bars/Bridges, NNC |
4
Straumann Variobase Abutment For Bars/Bridges, RN Straumann Variobase Abutment For Bars/Bridges, WN Straumann Variobase Abutment For Bars/Bridges, STRAUMANN USA, LLC. K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A
INDICATIONS FOR USE
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.
SUBJECT DEVICE DESCRIPTIONS
The GM Titanium Base for Bridge are prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Titanium Base for Bridge is a two-piece abutment used as a base when fabricating a CAD/CAM customized restoration. The planning and milling of the customized superstructures should be made using the validated Dental Wings Operating System (DWOS) or 3Shape Software. All digitally designed copings and/or crowns for use with the GM Titanium Base for Bridge are intended to be manufactured as a validated milling center. The limits for customization are stated in the GM Titanium Base for Bridge Instructions for Use. The superstructure produced through the CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Titanium Base for Bridge.
The main characteristics of the subject devices are the following:
- Intended for single use;
- Provided sterile via ethylene oxide gas;
- . Manufactured of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
- Conical format available in different diameters, height of cementable area and gingival height;
- Screw-retained;
- Provided in rotational (non-indexed) version supporting multi-unit restorations;
- Provided with an implant-to-abutment interface compatible with the GM implants of the Neodent Implant System.
5
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | |
|---|---|---|---|---|
| Indications for Use | K192229 | |||
| Neodent Implant System - GM Titanium | ||||
| Base for Bridge | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K180536 | |||
| Neodent Implant System - GM Line | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K151157 | |||
| NC Straumann Variobase Abutment For | ||||
| Bars/Bridges, RC Straumann Variobase | ||||
| Abutment For Bars/Bridges, NNC | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges, RN Straumann Variobase | ||||
| Abutment For Bars/Bridges, WN | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges | ||||
| Straumann USA, LLC | Equivalent | |||
| The subject devices bring specific | ||||
| information regarding the restoration | ||||
| type indicated to be used with them but | ||||
| the general indications are the same for | ||||
| both subject and the GM Exact Titanium | ||||
| Base abutments of the predicate device. | ||||
| Titanium Base Abutment is a titanium | ||||
| base placed onto Neodent dental | ||||
| implants to provide support for | ||||
| customized prosthetic restorations. It is | ||||
| used with a coping and crown, or crown | ||||
| alone, and is indicated for cement- | ||||
| retained single or multi-unit restorations | ||||
| or screw-retained single restorations. All | ||||
| digitally designed copings and/or crowns | ||||
| to be used with the Neodent Titanium | ||||
| Base Abutment System are intended to | ||||
| be sent to Straumann for manufacture at | ||||
| a validated milling center. | ||||
| The GM Titanium Base for Bridge is | ||||
| indicated for cement or screw-retained | ||||
| multi-unit restorations. | GM Helix Implants and conventional | |||
| abutments: | ||||
| The Neodent Implant System is intended | ||||
| to be surgically placed in the bone of the | ||||
| upper or lower jaw to provide support | ||||
| for prosthetic devices such as artificial | ||||
| teeth, to restore chewing function. It | ||||
| may be used with single-stage or two- | ||||
| stage procedures, for single or multiple | ||||
| unit restorations, and may be loaded | ||||
| immediately when good primary stability | ||||
| is achieved and with appropriate occlusal | ||||
| loading. | ||||
| GM Exact Titanium Block for Medentika | ||||
| Holder: | ||||
| GM Exact Titanium Block for Medentika | ||||
| Holder is a titanium abutment to be used | ||||
| in fabricating a full custom abutment and | ||||
| placed onto Neodent dental implants to | ||||
| provide support for customized | ||||
| prosthetic restorations. The GM Exact | ||||
| Titanium Block for Medentika Holder | ||||
| abutments are indicated for screw- | ||||
| retained single restorations or cement- | ||||
| retained single or multi-unit restorations. | ||||
| All digitally designed abutments for use | ||||
| with the GM Exact Titanium Block for | ||||
| Medentika Holder are intended to be | ||||
| sent to Straumann for manufacture at a | ||||
| validated milling center. | Straumann® Variobase™ prosthetic | |||
| components directly connected to the | ||||
| endosseous dental implants are | ||||
| indicated for use as an aid in prosthetic | ||||
| rehabilitations. The prosthetic | ||||
| restoration (bridge or overdenture) can | ||||
| be cemented on the Straumann® | ||||
| Variobase™ prosthetic components. A | ||||
| temporary restoration can be used prior | ||||
| to the insertion of the final components | ||||
| to maintain, stabilize and form the soft | ||||
| tissue during the healing phase. They | ||||
| may not be placed into occlusion. Final | ||||
| abutments and restorations may be | ||||
| placed into occlusion when the implant is | ||||
| fully osseointegrated. | ||||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
| K192229 | ||||
| Neodent Implant System - GM Titanium | ||||
| Base for Bridge | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K180536 | |||
| Neodent Implant System - GM Line | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K151157 | |||
| NC Straumann Variobase Abutment For | ||||
| Bars/Bridges, RC Straumann Variobase | ||||
| Abutment For Bars/Bridges, NNC | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges, RN Straumann Variobase | ||||
| Abutment For Bars/Bridges, WN | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges | ||||
| Straumann USA, LLC | EQUIVALENCE DISCUSSION | |||
| GM Exact Titanium Base abutments: | ||||
| Titanium Base Abutment is a titanium | ||||
| base placed onto Neodent dental | ||||
| implants to provide support for | ||||
| customized prosthetic restorations. It is | ||||
| used with a coping and crown, or crown | ||||
| alone, and is indicated for cement- | ||||
| retained single or multi-unit restorations, | ||||
| or screw-retained single restorations. All | ||||
| digitally designed copings and/or crowns | ||||
| for use with the Neodent Titanium Base | ||||
| Abutment System are intended to be | ||||
| sent to Straumann for manufacture at a | ||||
| validated milling center. | ||||
| Titanium Base C for GM Exact | ||||
| abutments: | ||||
| The Titanium Base C for GM Exact | ||||
| abutments is a titanium component that | ||||
| is placed over Neodent implants to | ||||
| provide support for custom prosthetic | ||||
| restorations, such as copings or crowns. | ||||
| It is indicated for single-tooth screw- | ||||
| retained restorations. All digitally | ||||
| designed copings and/or crowns for use | ||||
| with the Titanium Base C for GM Exact | ||||
| abutments are to be designed using | ||||
| Sirona inLab software or Sirona CEREC | ||||
| Software and manufactured using a | ||||
| Sirona CEREC or inLab MC X or MC XL | ||||
| milling unit. | ||||
| Implant-Abutment | ||||
| interface | GM | GM | N/A | Same as Primary Predicate |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
| K192229 | ||||
| Neodent Implant System - GM Titanium | ||||
| Base for Bridge | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K180536 | |||
| Neodent Implant System - GM Line | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K151157 | |||
| NC Straumann Variobase Abutment For | ||||
| Bars/Bridges, RC Straumann Variobase | ||||
| Abutment For Bars/Bridges, NNC | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges, RN Straumann Variobase | ||||
| Abutment For Bars/Bridges, WN | ||||
| Straumann Variobase Abutment For | ||||
| Bars/Bridges | ||||
| Straumann USA, LLC | EQUIVALENCE DISCUSSION | |||
| Straight | Straight | Straight | Equivalent | |
| Design | Conical upper portion | |||
| Helical micro grooves in the cementable | ||||
| portion | Cylindrical upper portion | |||
| Helical micro grooves in the cementable | ||||
| portion | Conical upper portion | |||
| Helical micro grooves in the cementable | ||||
| portion | The coronal design of the subject device | |||
| is equivalent to that of the reference | ||||
| device K151157. | ||||
| Reusable | No | No | No | Same |
| Diameter (Ø) | 3.5, 4.5, and 5.5 mm | 5.5 mm | 3.3 mm | Equivalent |
| The reference devices (K151157) have a | ||||
| minimum diameter of 3.3 mm which is | ||||
| similar to the subject devices. Dynamic | ||||
| fatigue testing was performed with the | ||||
| new worst-case design of the subject | ||||
| devices, the results indicate performance | ||||
| suitable for the intended use. | ||||
| Gingival Height | ||||
| (mm) | 0.8, 1.5, 2.5, 3.5, and 4.5 | 0.8, 1.5, 2.5, 3.5, 4.5, and 5.5 | N/A | Equivalent |
| Subject devices are within the range | ||||
| established by the primary predicate. | ||||
| Maximum | ||||
| Angulation | 30° | 30° | 30° | Same |
| Abutment Height | 4 mm | 4 mm | 3.5 – 5.2 mm | Same as Primary Predicate |
| Material | TAV (ASTM F136) | TAV (ASTM F136) | Ti-6Al-7Nb (TAN) | Same as Primary Predicate |
| Sterilization | ||||
| Method | Ethylene Oxide to an SAL of 1x10-6 | Ethylene Oxide to an SAL of 1x10-6 | Non-Sterile | Same as Primary Predicate |
6
7
8
The subject devices and the primary predicate device (K180536) have the same Indications for Use, similar design, similar range of gingival height, same raw material and same sterilization method.
PERFORMANCE DATA
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Titanium Base for Bridge, according to FDA Guidance. The abutments were tested with three different restoration materials and all of them are in accordance with the acceptance criteria.
Torsion testing was performed to evaluate the Titanium Base Screws under static torsional loading. The results met the acceptance criteria.
Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 10th has been validated.
Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Biological Safety Assessment guided by ISO 10993-1.
Cytotoxicity testing was performed per ISO 10993-5.
Chemical characterization was performed per ISO 10993-18.
Biocompatibility sample preparation was performed per ISO 10993-12.
CONCLUSION
The subject devices and the primary predicate devices K180536 have the same intended use, similar designs and technological characteristics, similar range of gingival height, same sterilization method and are made of the same materials. The data included in this submission demonstrate that the subject device is substantially equivalent to the predicate device.