(218 days)
No
The summary describes a standard dental implant system and its components, focusing on materials, sterilization, mechanical testing, and intended use. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The Neodent Implant System is surgically placed in the bone to support prosthetic devices, restoring chewing function and replacing teeth. These are clearly therapeutic actions.
No
The device description clearly states its purpose is for "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 functions as an implant system and prosthetic components, not to diagnose a condition or disease.
No
The device description clearly states the device is a physical implant system made of titanium and titanium alloy, intended for surgical placement. It also describes sterilization methods and mechanical testing, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The provided text clearly states the device's intended use is to be surgically placed in the bone of the jaw to support prosthetic devices for restoring chewing function. This is a surgical implant, not a device that analyzes biological samples.
- Device Description: The description focuses on the physical characteristics of the implants and abutments (material, shape, sterilization method), not on any analytical or diagnostic function.
- Lack of IVD-related information: The text does not mention any analysis of biological samples, diagnostic markers, or any other elements typically associated with IVD devices.
Therefore, based on the provided information, the Neodent Implant System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use for Helix NGM Implants:
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 procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.
Indications for 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.
Indications for Use for NGM Exact Temporary Abutments:
Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.
Indications for NGM Exact Titanium Bases:
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
- All the subject devices are intended for single use;
- The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
- The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
- The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)
- The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Biocompatibility:
- Biocompatibility sample preparation was made according to ISO 10993-12.
- Biological Safety Assessment guided by ISO 10993-1.
- Cytotoxicity testing was performed per ISO 10993-5.
- Chemical characterization was performed per ISO 10993-18.
Mechanical testing:
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Sterilization validation:
The subject implants are sterilized by Gamma Irradiation, according to ISO 11137-1 and ISO 11137-2, and the subject abutments by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10 °.
The Subject devices are not represented to be "pyrogen free".
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K220251
Trade/Device Name: Neodent Implant System - GM Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 4, 2022 Received: August 9, 2022
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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220251
Device Name
Neodent Implant System - GM Narrow Implant System
Indications for Use (Describe)
IIndications for Use for Helix NGM Implants:
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 procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.
Indications for 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.
Indications for Use for NGM Exact Temporary Abutments:
Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.
Indications for NGM Exact Titanium Bases:
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a 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)
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3
K220251 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
Sr. Director of Regulatory Affairs and Quality,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 06/Sep/2022 |
| Preparer / Alternate Contact | Mariana Hartmann
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: mariana.hartmann@neodent.com |
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Neodent Implant System – GM Narrow Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Endosseous dental implant abutment | |
| Classification Name | Implant, Endosseous, Root-Form |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE / NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate Device | K123022, Neodent Implant System, JJGC Indústria e
Comércio de Materiais Dentários S.A |
| -------------------------- | ------------------------------------------------------------------------------------------ |
|---|
4
| Reference Predicate Devices | |
|---|---|
| K162890 - Straumann Ø2.9 mm Bone Level Tapered | |
| Implants, SC Closure Cap, SC Healing Abutments, SC | |
| Temporary Abutments, SC Variobase Abutments, SC | |
| CARES Abutments - Straumann USA, LLC | |
| K203309 – NUVO CF Implant Line, JJGC Indústria e | |
| Comércio de Materiais Dentários S.A | |
| K182620 - MRI Compatibility For Existing Neodent | |
| Implant System, JJGC Indústria e Comércio de Materiais | |
| Dentários S.A |
INDICATIONS FOR USE
Indications for Use for Helix NGM Implants:
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. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.
Indications for 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.
Indications for Use for NGM Exact Temporary Abutments:
Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installed in the maxilla or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.
Indications for NGM Exact Titanium Bases:
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
SUBJECT DEVICE DESCRIPTIONS
- All the subject devices are intended for single use;
- The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
- The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
- The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)
5
- The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
SUBSTANTIAL EQUIVALENCE COMPARISON TABLES
The Substantial Equivalence Comparison tables are provided on the pages that follow below.
6
Table 1: Substantial Equivalence Comparison – Indix NGM Implants and Conventional and Temporary Abutments
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE | |
|---|---|---|---|
| COMPARISON | Neodent Implant System - Narrow Implant System | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K123022 | ||
| Neodent Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890 | ||
| Straumann Ø2.9 mm Bone Level Tapered | |||
| Implants, SC Closure Cap, SC Healing | |||
| Abutments, SC Temporary Abutments, SC | |||
| Variobase Abutments, SC CARES Abutments | |||
| Straumann USA, LLC | |||
| Indications | |||
| for Use | |||
| Statement | Indications for Use for Helix NGM Implants: | ||
| 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. The Implant Narrow GM is indicated to replace upper | |||
| lateral incisors, lower incisors or for retaining overdenture | |||
| prostheses. | |||
| Indications for Use for 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. | |||
| Indications for Use for NGM Exact Temporary Abutments: | |||
| Prosthetic component to be installed in the Narrow GM | |||
| Implant, providing support for prosthetic structures. Indicated | |||
| for temporary restorations with unitary structures, screwed, | |||
| on implants installed in the maxilla or mandible. Temporary | |||
| Abutments Narrow GM have a maximum duration of usage of | |||
| 180 days. | |||
| Indications for Use for NGM Exact Titanium Bases: | |||
| Titanium Base Abutment is a titanium base placed onto | |||
| Neodent dental implants to provide support for customized | |||
| prosthetic restorations as copings and crowns. It is indicated | 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. | |||
| Titamax WS implant is indicated for a delayed loading | |||
| protocol. | |||
| The Facility implant is indicated to replace upper lateral | |||
| incisors, lower incisors or for retaining overdenture | |||
| prostheses. | Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for | ||
| oral endosteal implantation in the upper and lower jaw and for the | |||
| functional and aesthetic oral rehabilitation of patients with missing | |||
| teeth. Straumann® Bone Level Tapered Implants Ø2.9 mm can also | |||
| be used for immediate or early implantation following extraction or | |||
| loss of natural teeth. Implants can be placed with immediate | |||
| function on single-tooth or multiple-tooth applications when good | |||
| primary stability is achieved and with appropriate occlusal loading | |||
| to restore chewing function. The prosthetic restorations are | |||
| connected to the implants through the corresponding components | |||
| (abutments). The Straumann® Bone Level Tapered Implants Ø2.9 | |||
| mm are indicated for reconstruction of missing incisors in the lower | |||
| jaw and lateral incisors in the upper jaw. | |||
| 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. | |||
| Straumann® SC Temporary Abutments are indicated for use as an | |||
| aid in prosthetic rehabilitations. Temporary components can be | |||
| used prior to the insertion of the final components to maintain, | |||
| stabilize and shape the soft tissue during the healing phase. | |||
| Straumann® SC Temporary Abutments have a maximum duration of | |||
| usage of 180 days. | |||
| Straumann® SC Variobase® abutments are indicated for use as an aid | |||
| in prosthetic rehabilitations. The prosthetic restoration can be | |||
| cemented on the Straumann® SC Variobase® prosthetic | |||
| SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE | |
| COMPARISON | Neodent Implant System - Narrow Implant System | ||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K123022 | ||
| Neodent Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890 | ||
| Straumann Ø2.9 mm Bone Level Tapered | |||
| Implants, SC Closure Cap, SC Healing | |||
| Abutments, SC Temporary Abutments, SC | |||
| Variobase Abutments, SC CARES Abutments | |||
| Straumann USA, LLC | |||
| for cemented or screw mounted single-cemented applications | |||
| on implants installed on the maxilla or mandible. All digitally | |||
| designed copings and/or crowns to be used with the Titanium | |||
| Base Abutment System are intended to be sent to Straumann | |||
| for manufacture at a validated milling center. | 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. Final abutments and | |||
| restorations may be placed into occlusion when the implant is fully | |||
| osseointegrated. All digitally designed copings and/or crowns for use | |||
| with the Straumann® Variobase® Abutment system are intended to | |||
| be sent to Straumann for manufacture at a validated milling center. |
Straumann® SC CARES® abutments are indicated for single-tooth
replacements and multiple tooth restorations. The prosthetic
restoration can be cemented or directly veneered/screw-retained. |
7
Neodent Implant System – GM Narrow Implant System
Table 2: Substantial Equivalence Comparison – Indication for Use Statements - Titanium Bases
| COMPARISON | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE |
|---|---|---|---|
| K203309 | K162890 | ||
| Neodent Implant System - Narrow Implant System | |||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | NUVO CF Implant System | ||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | Straumann Ø2.9 mm Bone Level Tapered | ||
| Implants, SC Closure Cap, SC Healing | |||
| Abutments, SC Temporary Abutments, SC | |||
| Variobase Abutments, SC CARES Abutments | |||
| Straumann USA, LLC | |||
| Indications | |||
| for Use | |||
| Statement | Indications for Use for NGM Exact Titanium Bases: | ||
| Titanium Base Abutment is a titanium base placed onto | |||
| Neodent dental implants to provide support for customized | |||
| prosthetic restorations as copings and crowns. It is indicated | |||
| for cemented or screw mounted single-cemented applications | |||
| on implants installed on the maxilla or mandible. All digitally | |||
| designed copings and/or crowns to be used with the Titanium | |||
| Base Abutment System are intended to be sent to Straumann | |||
| for manufacture at a validated milling center. | CF Titanium Base for Crown is a titanium abutment placed | ||
| onto dental implants to provide support for customized | |||
| prosthetic restorations, as copings or crowns. It is indicated | |||
| for single-unit restorations, cement-retained or screw- | |||
| retained in aesthetic areas on implants installed in the | |||
| maxilla or mandible. All digitally designed copings and/or | |||
| crowns to be used with the Titanium Base Abutment System | |||
| are intended to be sent to Straumann for manufacture at a | |||
| validated milling center. | Straumann® SC Variobase® abutments are indicated for use as an aid in | ||
| prosthetic rehabilitations. The prosthetic restoration can be cemented | |||
| on the Straumann® SC 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. | |||
| Final abutments and restorations may be placed into occlusion when the | |||
| implant is fully osseointegrated. All digitally designed copings and/or | |||
| crowns for use with the Straumann® Variobase® Abutment system are | |||
| intended to be sent to Straumann for manufacture at a validated milling | |||
| center. |
8
Equivalence Discussion about Indications for Use
Implants
The scope of the Indications for Use Statement for the subject Implants (K220251) are identical to the corresponding section of the Indications for Use Statement of the Facility Implant of primary predicate devices (K123022) and similar to the reference predicate devices (K162890).
| PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
|---|---|---|
| SUBJECT DEVICE | K123022 | K162890 |
| 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. The Implant Narrow GM | ||
| is indicated to replace upper | ||
| lateral incisors, lower incisors or | ||
| for retaining | ||
| overdenture | ||
| prostheses. | 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. | ||
| Titamax WS implant is indicated | ||
| for a delayed loading protocol. | ||
| The Facility implant is indicated to | ||
| replace upper lateral incisors, | ||
| lower incisors or for retaining | ||
| overdenture prostheses. | Straumann® Bone Level Tapered Implants Ø2.9 mm | |
| are indicated for oral endosteal implantation in the | ||
| upper and lower jaw and for the functional and | ||
| aesthetic oral rehabilitation of patients with missing | ||
| teeth. Straumann® Bone Level Tapered Implants | ||
| Ø2.9 mm can also be used for immediate or early | ||
| implantation following extraction or loss of natural | ||
| teeth. Implants can be placed with immediate | ||
| function on single-tooth or multiple-tooth | ||
| applications when good primary stability is achieved | ||
| and with appropriate occlusal loading to restore | ||
| chewing function. The prosthetic restorations are | ||
| connected to the implants through the | ||
| corresponding components (abutments). The | ||
| Straumann® Bone Level Tapered Implants Ø2.9 mm | ||
| are indicated for reconstruction of missing incisors | ||
| in the lower jaw and lateral incisors in the upper jaw. |
Conventional and Temporary Abutments
The indications for use of the Conventional Abutments is the same for the subject devices and primary predicate device (K123022). Regarding the Temporary Abutments, although the wording is slightly different, the indications for use are the same (K162890).
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|
| K123022 | K162890 | |
| Conventional Abutments: | Conventional Abutments: | Temporary 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. |
Temporary 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 artificialteeth, 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. | Straumann® SC Temporary
Abutments are indicated for use as
an aid in prosthetic rehabilitations.
Temporary components can be
used prior to the insertion of the
final components to maintain,
stabilize and shape the soft tissue
during the healing phase.
Straumann® SC Temporary
Abutments have a maximum
duration of usage of 180 days. |
| Prosthetic component to be installed in the
Narrow GM Implant, providing support for
prosthetic structures. Indicated for temporary
restorations with unitary structures, screwed,
on implants installed in the maxilla or mandible.
Temporary Abutments Narrow GM have a
maximum duration of usage of 180 days. | | |
9
Titanium Bases Abutments
The Indications for Use Statement for the subject device are equivalent to the corresponding section of the Indications for Use Statement of K203309 and K162890. Although the wording is slightly different, the Indications for the subject devices are included within the scope on Indications for the predicate devices.
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|
| K203309 | K162890 | |
| Titanium Base Abutment is a | ||
| titanium base placed onto Neodent | ||
| dental implants to provide support | ||
| for customized prosthetic | ||
| restorations as copings and crowns. | ||
| It is indicated for cemented or screw | ||
| mounted single-cemented | ||
| applications on implants installed on | ||
| the maxilla or mandible. | ||
| All digitally designed copings and/or | ||
| crowns to be used with the Titanium | ||
| Base Abutment System are intended | ||
| to be sent to Straumann for | ||
| manufacture at a validated milling | ||
| center. | CF Titanium Base for Crown is a titanium | |
| abutment placed onto dental implants to | ||
| provide support for customized prosthetic | ||
| restorations, as copings or crowns. It is | ||
| indicated for single-unit restorations, | ||
| cement-retained or screw-retained in | ||
| aesthetic areas on implants installed in the | ||
| maxilla or mandible. All digitally designed | ||
| copings and/or crowns to be used with the | ||
| Titanium Base Abutment System are | ||
| intended to be sent to Straumann for | ||
| manufacture at a validated milling | ||
| center. | Straumann® SC Variobase® | |
| abutments are indicated for use as an | ||
| aid in prosthetic rehabilitations. The | ||
| prosthetic restoration can be | ||
| cemented on the Straumann® SC | ||
| 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. Final abutments and | ||
| restorations may be placed into | ||
| occlusion when the implant is fully | ||
| osseointegrated. All digitally designed | ||
| copings and/or crowns for use with the | ||
| Straumann® Variobase® Abutment | ||
| system are intended to be sent to | ||
| Straumann for manufacture at a | ||
| validated milling center. |
A comparison of the technological characteristics of the subject device and the predicate and reference devices is provided in the following table.
10
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | Equivalence Discussion | |
|---|---|---|---|---|
| Implant- | ||||
| Abutment | ||||
| interface | K220251 | |||
| Neodent Implant System - Narrow Implant | ||||
| System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K123022 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K162890 | |||
| Straumann Ø2.9 mm Bone Level Tapered | ||||
| Implants, SC Closure Cap, SC Healing | ||||
| Abutments, SC Temporary Abutments, SC | ||||
| Variobase Abutments, SC CARES Abutments | ||||
| Straumann USA, LLC | Similar | |||
| All the devices have Internal implant to | ||||
| abutment connection. The difference | ||||
| between the primary predicate and the | ||||
| subject devices has been proven to | ||||
| increase the system resistance (bench | ||||
| testings). | ||||
| Design | Grand Morse Internal Connection | Cone Morse Internal Connection | Straight implant with apical taper. | Identical |
| Subject devices and Primary Predicate | ||||
| devices present the same design and | ||||
| surface treatment. | ||||
| Reusable | Cylindrical format with double threads; | |||
| cervical diameter equal to diameter of | ||||
| implant body; | ||||
| Surface: Neoporos and Acqua. | Cylindrical format with double threads; | |||
| cervical diameter equal to diameter of | ||||
| implant body; | ||||
| Surface: Neoporos and Acqua. | No | Identical | ||
| The subject devices and the predicate devices | ||||
| are indicated for single use. | ||||
| Length (mm) | No | No | 10; 12; 14 | Equivalent |
| Range of lengths for subject devices is | ||||
| contained within the range of lengths for | ||||
| the primary predicate devices and is the | ||||
| same as of the reference predicate devices. | ||||
| Diameter (Ø) | ||||
| (mm) | 10; 12; 14 | 8; 10; 12; 14; 16 | 2.9 | Identical |
| All the devices present the same diameter. | ||||
| 2.9 | 2.9 |
Table 3. Technological Characteristic Comparison Table – Helix NGM Implants
11
Neodent Implant System – GM Narrow Implant System
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | ||
|---|---|---|---|---|
| K220251 | ||||
| Neodent Implant System - Narrow Implant | ||||
| System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K123022 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K162890 | |||
| Straumann Ø2.9 mm Bone Level Tapered | ||||
| Implants, SC Closure Cap, SC Healing | ||||
| Abutments, SC Temporary Abutments, SC | ||||
| Variobase Abutments, SC CARES Abutments | ||||
| Straumann USA, LLC | Equivalence | |||
| Discussion | ||||
| Material | Commercially Pure Titanium (Grade 4) | Commercially Pure Titanium (Grade 4) | Titanium-13 Zirconium alloy (Roxolid®) | Identical |
| Subject devices and Primary Predicate | ||||
| devices are manufactured of the same raw | ||||
| material. | ||||
| Sterilization | ||||
| Method | Provided sterile via gamma irradiation to | |||
| an SAL of 10-6. | Provided sterile via gamma irradiation to an | |||
| SAL of 10-6. | Identical | |||
| Subject devices and primary predicate devices | ||||
| are provided sterile by the same sterilization | ||||
| method. | ||||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | Equivalence Discussion | ||
| Neodent Implant System - Narrow Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A.. | K123022 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890 | |||
| Straumann Ø2.9 mm Bone Level | ||||
| Tapered Implants, SC Closure Cap, SC | ||||
| Healing Abutments, SC Temporary | ||||
| Abutments, SC Variobase Abutments, | ||||
| SC CARES Abutments | ||||
| Straumann USA, LLC | ||||
| NGM Exact Click | ||||
| Universal | ||||
| abutments | ||||
| design | Gingival height: 0,8; 1.5, 2.5, and 3.5 | Gingival height: 1.5, 2.5, 3.5; 4.5 and 5.5 | Equivalent | |
| Range of lengths for subject | ||||
| devices is very similar to the | ||||
| primary predicate devices and is | ||||
| the same as of the reference | ||||
| predicate devices. | ||||
| NGM Micro | ||||
| abutments | ||||
| design | Gingival height: 0,8; 1.5, 2.5, and 3.5 | Gingival height: 1.5, 2.5, 3.5 and 4.5 | Equivalent | |
| Range of lengths for subject | ||||
| devices is very similar to the | ||||
| primary predicate devices and is | ||||
| the same as of the reference | ||||
| predicate devices. | ||||
| Healing | ||||
| abutments | ||||
| design | Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5 | Gingival height: 1.5, 2.5, 3.5 and 4.5 | Equivalent | |
| Range of lengths for subject | ||||
| devices is very similar to the | ||||
| primary predicate devices and is | ||||
| the same as of the reference | ||||
| predicate devices. | ||||
| Temporary | ||||
| abutments | ||||
| design | Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5 | Gingival height: 1.0, 2.0, and 3.0 | ||
| mm | Equivalent | |||
| Range of lengths for subject | ||||
| devices is very similar to the | ||||
| primary predicate devices and is | ||||
| the same as of the reference | ||||
| predicate devices. The difference | ||||
| between the reference predicate | ||||
| and the subject devices has been | ||||
| mitigated during performance | ||||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | Equivalence | ||
| Discussion | ||||
| Neodent Implant System - Narrow Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A.. | K123022 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890 | |||
| Straumann Ø2.9 mm Bone Level | ||||
| Tapered Implants, SC Closure Cap, SC | ||||
| Healing Abutments, SC Temporary | ||||
| Abutments, SC Variobase Abutments, | ||||
| SC CARES Abutments | ||||
| Straumann USA, LLC | ||||
| bench tests. | ||||
| Attachments | ||||
| Narrow GM | ||||
| design | Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5 | |||
| Surface Treatment: NiT Coating | Gingival height: 1.5, 2.5, 3.5 and 4.5 | |||
| Surface Treatment: NiT Coating | Equivalent | |||
| Range of lengths for subject | ||||
| devices is very similar to the | ||||
| primary predicate devices and is | ||||
| the same as of the reference | ||||
| predicate devices. | ||||
| Both subject and predicate | ||||
| devices present the same surface | ||||
| treatment. | ||||
| Reusable | No | No | No | Identical |
| The subject devices and predicates | ||||
| devices are indicated for single use. | ||||
| Material | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Ti-6Al-7Nb | Identical |
| The subject devices and | ||||
| predicates devices are | ||||
| manufactured of the same raw | ||||
| material. | ||||
| Sterilization | ||||
| Method | Provided sterile via Ethylene Oxide to an SAL of | |||
| $10^{-6}$ . | Provided sterile via Ethylene Oxide to an SAL of $10^{-6}$ . | Provided sterile via Ethylene | ||
| Oxide to an SAL of $10^{-6}$ . | Identical | |||
| The subject devices and the primary | ||||
| predicate devices are provided in | ||||
| sterile condition to an SAL of 1 x $10^{-6}$ | ||||
| by the same sterilization method. | ||||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |
| Neodent Implant System - Narrow Implant | ||||
| System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K203309 | |||
| NUVO CF Implant System | ||||
| JJGC Indústria e Comércio de Materiais | ||||
| Dentários S.A. | K162890 | |||
| Straumann Ø2.9 mm Bone Level Tapered | ||||
| Implants, SC Closure Cap, SC Healing | ||||
| Abutments, SC Temporary Abutments, SC | ||||
| Variobase Abutments, SC CARES Abutments | ||||
| Straumann USA, LLC | ||||
| Implant- | ||||
| Abutment | ||||
| interface | Grand Morse Internal Connection | Internal Hex | Small CrossFit® (SC) | Equivalent |
| Subject devices and Primary Predicate devices | ||||
| present internal connection implant-abutment | ||||
| interface. | ||||
| Design | Angulation: 0 | |||
| Gingival Height: 0.8; 1.5; 2.5; 3.5 and 4.5 | ||||
| Cementable portion height: 4.0 and 6.0 | Angulation: 0 | |||
| Gingival Height: 0.5, 1.0 and 3.0 mm | ||||
| Cementable portion height: 6.0 | Angulation: 0 | |||
| Gingival Height: 1.0, 2.0 and 3.0 mm | Equivalent | |||
| All the devices are straight, the gingival | ||||
| height of the subject devices is similar to the | ||||
| range of gingival height of the predicate | ||||
| devices and bench tests were performed to | ||||
| verify the strength of the system. | ||||
| Reusable | No | No | No | Identical |
| The subject devices and the predicate devices | ||||
| are intended for single use. | ||||
| Material | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Ti-6Al-7Nb | Identical |
| The subject devices have the same material of | ||||
| construction as the primary predicate devices. |
12
Neodent Implant System – GM Narrow Implant System
Table 4. Technological Characteristic Comparison Table – Conventional and Temporary Abutments
13
Neodent Implant System – GM Narrow Implant System
14
Neodent Implant System – GM Narrow Implant System
Table 5. Technological Characteristic Comparison Table – CAD/CAM Abutments (Titanium Bases)
15
Neodent Implant System – GM Narrow Implant System
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Neodent Implant System - Narrow Implant System | ||||||||||
| JJGC Indústria e Comércio de Materiais | ||||||||||
| Dentários S.A. | K203309 | |||||||||
| NUVO CF Implant System | ||||||||||
| JJGC Indústria e Comércio de Materiais | ||||||||||
| Dentários S.A. | K162890 | |||||||||
| Straumann Ø2.9 mm Bone Level Tapered | ||||||||||
| Implants, SC Closure Cap, SC Healing | ||||||||||
| Abutments, SC Temporary Abutments, SC | ||||||||||
| Variobase Abutments, SC CARES Abutments | ||||||||||
| Straumann USA, LLC | ||||||||||
| Top Half Materials | Material | Minimum thickness (mm) | Maximum allowable angulation | Material | Minimum thickness (mm) | Maximum allowable angulation | Material | Minimum thickness (mm) | Maximum allowable angulation | |
| Coron (CoCr) | 0.3 | 30° | Coron (CoCr) | 0.3 | 30° | Coron (CoCr) | 0.3 | 30° | Same | |
| The subject top half materials are the same | ||||||||||
| the cleared top half materials for the primary | ||||||||||
| predicate device and using the same cleared | ||||||||||
| design parameters. | ||||||||||
| IPS e.max CAD | 0.9 | IPS e.max CAD | 0.9 | IPS e.max CAD | 0.9 | |||||
| Zerion LT | 0.5 | Zerion LT | 0.5 | Zerion LT | 0.4 | |||||
| Polycon ae* | 1.0 | Polycon ae* | 1.0 | Polycon ae* | 0.5 | |||||
| The Narrow GM Titanium Base with cementable area height of 6 mm allows customization. In case of customization, it is indicated to maintain the minimum height of 4 mm of cementable area. | The CF Titanium Base for Crown with 6 mm Incementable height are supplied without angulation, but allow customization by reducing the height of cementable area to 4 mm. | *Polycon ae is indicated to remain in the mouth only for up to 180 days | ||||||||
| *Polycon ae is indicated to remain in the mouth only for up to 180 days. | *Polycon ae is indicated to remain in the mouth only for up to 180 days | |||||||||
| Sterilization Method | Provided sterile via Ethylene Oxide to an SAL of 1x10-6 |
If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 3 minutes exposure. | | | Provided sterile via Ethylene Oxide to an SAL of 1x10-6
If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 3 minutes exposure. | | | Delivered not sterile. If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 4 minutes exposure. | | | Identical
The subject devices have the same sterilization methods and same SAL as the primary predicate devices. |
16
The subject implants have the same indications for use and an equivalent range of lengths as the primary predicate devices, being contemplated within the range of lengths of the predicate devices.
Subject and predicate implants have the similar implant-to-abutment interface. Both present the same surfaces and same sterile barrier system. The subject implants are manufactured of the same materials and are sterilized using the same sterilization method as the primary predicate devices. Subject and reference predicate devices present the same range of sizes and similar overall design.
The subject conventional abutments have the same indications for use and same overall design as the primary predicate devices. They also present the same sterilization method and raw materials.
The subject Base abutments have the same indications for use, same maximum angulation and same gingival height as the primary predicate devices and primary predicate devices, present the same sterilization method. The subject bases are made of the same material as the primary predicate devices and are indicated to be used with the same restoration materials of the predicate devices. All digitally designed copings and/or crowns for use with the subject Titanium Bases are intended to be sent to Straumann for manufacture at a validated milling center.
Overall, the subject devices are equivalent to the predicate devices as follows:
- same intended use,
- same operating principle,
- . incorporate the same basic design,
- incorporate the same materials, and
- have same packaging and are sterilized using the same materials and processes
PERFORMANCE DATA
Biocompatibility
Representative samples of each of the subject devices was subjected to the following:
- . Biocompatibility sample preparation was made according to ISO 10993-12.
- Biological Safety Assessment guided by ISO 10993-1,
- Cytotoxicity testing was performed per ISO 10993-5 and
- . Chemical characterization was performed per ISO 10993-18.
Mechanical testing
Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Sterilization validation
The subject implants are sterilized by Gamma Irradiation, according to ISO 11137-1 and ISO 11137-2, and the subject abutments by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10 °.
The Subject devices are not represented to be "pyrogen free".
17
CONCLUSION
The subject devices and the predicate devices have equivalent intended use, design and technological characteristics. Equivalent range of overall dimensions and sterilization method. The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.