(118 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, sterilization, and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to be surgically placed in the jaw to support prosthetic devices, restore chewing function, and provide temporary support for prosthesis structure, which are all therapeutic actions.
No
The device is an implant system designed to provide support for prosthetic devices (artificial teeth) to restore chewing function. Its purpose is structural and functional replacement, not diagnosis. The "Performance Studies" section details mechanical, sterilization, and biocompatibility tests, none of which indicate a diagnostic function.
No
The device description clearly outlines physical components made of titanium and titanium alloy, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "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." This describes a surgical implant used for structural support within the body.
- Device Description: The description details physical components like implants, abutments, and screws made of titanium. It also mentions sterilization methods and mechanical properties. These are characteristics of a medical device intended for implantation, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and structural.
Therefore, the Neodent Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
- Intended for single use;
- The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
- The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
- . All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
- . The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
- . Implant and Cover Screw delivered sterile via Gamma Radiation;
- Sterile Abutments provided sterile via Ethylene Oxide;
- The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
- . The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
- The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
- . The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
- . The implant to abutment interface is a Grand Morse (GM) connection.
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)
Sterilization:
- Gamma Radiation validation based on ISO 11137-2 Parts 1, 2 and 3. Acceptance criteria: SAL of 10^-6 with a Dose of 25 kGy. Result: Passed. Same method as K163194.
- Ethylene Oxide validation based on ISO 11135:2014 Part 1. Acceptance criteria: SAL of 10^-6. Result: Passed. Same method as K163194 and K191191. EO sterilization residuals less than max allowable limits per ISO 10993-7.
- Steam Sterilization (moist heat 132 C, 3 mins, unwrapped) validated by overkill method to SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2. Result: Passed. Same method as K163194.
Shelf Life:
- Sealing Strength test based on ASTM F88. Acceptance criteria: resistance between 1.5 N and 15 N for specimens with width of 15 ± 1 mm. Result: Passed.
- Dye Penetration test based on ASTM F1929. Acceptance criteria: no dye solution leakage through the blister sealing. Result: Passed.
- Bubble Test based on ASTM F2096. Acceptance criteria: no constant flow of bubbles in the sealed area of the blister indicating a failure area. Result: Passed.
Shelf life for Easy Pack System is 4 years, leveraged from K193592.
Biocompatibility:
- Chemical Characterization based on ISO 10993-12 and ISO 10993-18. Acceptance criteria: MOS > 1 or HI 1 or HI
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K203382
Trade/Device Name: Neodent Implant System-Easy Pack Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 11, 2021 Received: February 12, 2021
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 (OS) 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 Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203382
Device Name Neodent Implant System - Easy Pack
Indications for Use (Describe)
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 GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | 15/Mar/2021 |
| Preparer / Alternate Contact | Mariana Soares 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 – Easy Pack |
|---|---|
| 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 | Primary: DZE |
| Secondary: NHA | |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate Device | K163194 | - Neodent Implant System - GM Line, JJGC Indústria e
Comércio de Materiais Dentários S.A |
|----------------------------|---------|------------------------------------------------------------------------------------------------------------------|
| Reference Predicate Device | K191191 | - Neodent Implant System - Temporary Abutments, JJGC
Indústria e Comércio de Materiais Dentários S.A |
| Reference Predicate Device | K182620 | - MRI Compatibility for Existing Neodent Implant System, JJGC
Indústria e Comércio de Materiais Dentários S.A |
| Reference Predicate Device | K193592 | - Change in the Shelf Life for Neodent Acqua Implants, JJGC
Indústria e Comércio de Materiais Dentários S.A |
4
INDICATIONS FOR USE
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 GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
SUBJECT DEVICE DESCRIPTIONS
- Intended for single use;
- The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
- The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
- . All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
- . The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
- . Implant and Cover Screw delivered sterile via Gamma Radiation;
- Sterile Abutments provided sterile via Ethylene Oxide;
- The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
- . The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
- The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
- . The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
- . The implant to abutment interface is a Grand Morse (GM) connection.
The compatibility table for both GM Helix implants and GM Smart abutments is presented below (all combinations available within each row):
| Implant Diameter | Implant Length | Abutment diameter | Abutment Gingival Heights |
|---|---|---|---|
| 3.5 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 3.75 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 4.0 mm | 8, 10, 11.5, 13 mm | 3.5 and 4.5 mm | 1.5, 2.5, 3.5 mm |
| 4.3 mm | 8, 10, 11.5, 13 mm | 4.5 mm | 1.5, 2.5, 3.5 mm |
5
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |||
|---|---|---|---|---|
| Neodent Implant System - Easy Pack System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194 | |||
| Neodent Implant System - GM Line | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | Equivalence | |||
| Discussion | ||||
| Indications for Use | 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 | ||||
| GM Easy Pack System is indicated to be used on | ||||
| Neodent implants to provide temporary support for | ||||
| prosthesis structure for up to 6 months. | for GM 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. |
for GM 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.
for GM Pro Peek Abutments:
The Pro PEEK Abutments are indicated to be used on
Neodent implants to provide temporary support for
prosthesis structure for up to 6 months. They can be
used in one or two stage procedures and also
immediate load when there is good primary stability. | Similar
Subject devices and predicate devices share the same
indications for use. The predicate for the subject
implants and cover screw is the GM implants and
conventional abutments of K163194. The temporary
indication is covered by the GM Pro Peek Abutments of
K163194. | |
| Implant-Abutment
interface | GM Morse Taper | GM Morse Taper | Identical
Subject devices and predicate devices present the
same Implant-to-abutment interface. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| | Neodent Implant System - Easy Pack System
JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais Dentários S.A. | Equivalence
Discussion | |
| Implant Design | Conical shape, double threads with trapezoidal
profile, rounded apex | Conical shape, double threads with trapezoidal
profile, rounded apex | Identical
Subject devices and predicate devices present the
same design | |
| Cover Screw Design | One end with a slot for the recommended
driver/connection and the other end with an
interface compatible with the GM prosthetic
interface | One end with a slot for the recommended
driver/connection and the other end with an interface
compatible with the GM prosthetic interface | Identical
Subject devices and predicate devices present the
same design | |
| Reusable | No | No | Identical
The subject devices and the predicate devices are
indicated for single use. | |
| Implant Diameter (Ø)
(mm) | 3.5, 3.75, 4.0 and 4.3 mm | 3.5, 3.75, 4.0, 4.3 and 5.0 mm | Equivalent
Diameter of subject devices is within the range of
diameters for the primary and reference predicate
devices, so the subject devices do not represent a worst
case in terms of performance. | |
| Implant Length (mm) | 8, 10, 11.5 and 13 mm | 8, 10, 11.5, 13, 16 and 18 mm | Equivalent
Range of lengths for subject devices is within the
range of lengths for the primary and reference
predicate devices. | |
| Material | Implant - Titanium grade 4 conforming to ASTM F67
Cover Screw - Titanium alloy conforming to ASTM
F136 | Implant - Titanium grade 4 conforming to ASTM F67
Cover Screw - Titanium alloy conforming to ASTM
F136 | Identical
Subject devices and predicate devices are
manufactured of the same raw material | |
| Surface | Neoporos
Acqua | Neoporos
Acqua | Identical
Subject devices and predicate devices present the
same surface | |
| Sterilization Method | Provided sterile via Gamma Radiation to an SAL of
1x10-6 | Implant - Provided sterile via Gamma Radiation to an
SAL of 1x10-6
Cover Screw - Provided sterile via Ethylene Oxide to an
SAL of 1x10-6 | Equivalent
Subject devices and predicate devices are provided
sterile by the same sterilization method.
The subject Cover Screw provided along with the Implant
is delivered sterile via Gamma Irradiation and when
commercialized separately, provided sterile via Ethylene
Oxide. Detailed information are provided in Section 14. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | Equivalence
Discussion |
| | Neodent Implant System - Easy Pack System
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K191191
Neodent Implant System - Temporary
Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A. | |
| Indications
for Use | 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 GM Easy Pack System is indicated
to be used on Neodent implants to provide
temporary support for prosthesis structure for
up to 6 months. | for GM 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.
for GM 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.
for GM Pro Peek Abutments:
The Pro PEEK Abutments are indicated to be
used on Neodent implants to provide
temporary support for prosthesis structure for
up to 6 months. They can be used in one or
two stage procedures and also immediate
load when there is good primary stability. | 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 Neodent Implant System -
Temporary Abutments are indicated to be
used on Neodent implants to provide
temporary support for prosthesis structure for
up to 6 months. | Similar
Subject devices and predicate devices
share similar indications for use. Subject
devices present the same indications for
use as reference predicate devices
(K191191). |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
| | Neodent Implant System - Easy Pack System
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K191191
Neodent Implant System - Temporary
Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A. | Equivalence
Discussion |
| Intended Use | GM Smart Abutment: Hybrid component that
has three functions. It can be used as a
scanbody, conventional closed tray transfer or
temporary component. With scanbody
function, the product is used to transfer the
position and orientation of the implants to the
digital model (scan) or plaster model
(conventional). For use as a temporary
component, the GM Smart Abutment is used
for temporary rehabilitation (up to 180 days)
with screw retrained single-unit protheses.
The GM Smart Abutment is only used with
implants placed straight (i.e no divergence)
and is available in the GM prosthetic interface
and must be used only with implants of
corresponding interface. | | The Temporary Abutment is used for
temporary rehabilitation (up to 180 days) with
screw retained single-unit (antirotational
abutment) or multi-unit (rotational abutment)
prostheses.
Temporary Abutments are only to be used
with implants placed straight (i.e. no
divergence).
This product is available in the GM prosthetic
interface and must be used only with implants
of corresponding interface. | Similar
The scanbody and conventional closed
tray transfer applications are exempt of
registration, so it is not being
considered in the comparison. The GM
Smart Abutment application as
temporary abutment is similar to the
Temporary Abutment of K191191. |
| Implant-
Abutment
interface | GM Morse Taper | GM Morse Taper | GM Morse Taper | Identical
Subject devices and predicate devices
present the same Implant-to-abutment
interface. |
| Reusable | No | No | No | Identical
The subject devices and the predicate
devices are indicated for single use. |
| Gingival Height
(mm) | GM Healing Abutment - 1.5, 2.5 and 3.5
mm
GM Smart Abutment - 1.5, 2.5 and 3.5
mm | GM Healing Abutment - 0.8, 1.5, 2.5,
3.5, 4.5, 5.5 mm | GM Temporary Abutments - 0.8; 1.5; 2.5
and 3.5 mm | Equivalent
Range of size of gingival heights tor
subject devices is within the range of
sizes for the primary and reference
predicate devices. |
| Material | Titanium alloy conforming to ASTM
F136 | Titanium alloy conforming to ASTM
F136 | Titanium alloy conforming to ASTM F136 | Identical
Subject devices and predicate devices
are manufactured of the same raw
material |
| Sterilization
Method | Provided sterile via Ethylene Oxide to
an SAL of 1x10-6 | Provided sterile via Ethylene Oxide to an
SAL of 1x10-6 | Provided sterile via Ethylene Oxide to an
SAL of 1x10-6 | Identical
Subject devices and predicate devices are
provided sterile by the same sterilization
method. |
Table 1. Technological Characteristic Comparison Table – Implants and Cover Screw
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Table 2. Technological Characteristic Comparison Table - Abutments
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The subject devices have the same indications for use as the primary predicate devices. They also present an equivalent range of lengths and diameter as the predicate devices, being contemplated within the range of lengths and diameter of the predicate devices.
Subject and predicate devices have the same implant-to-abutment interfaces. They present the same sterile barrier system and same sterilization methods. The subject devices and predicate devices are manufactured of the same materials.
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
NON-CLINICAL PERFORMANCE DATA
Sterilization
- . Gamma Radiation
The Gamma Radiation validation is based on the ISO 11137-2 Parts 1, 2 and 3. The purpose of this validation is to define the minimum dose Validation and Refer the Maximum dose approved by the client. The subject devices present the same sterilization method already validated for the predicate devices in K163194. The acceptance criteria is SAL of 10° with a Dose of 25 kGy and the result of the validation is passed.
● Ethylene Oxide
The Ethylene Oxide validation is based on the ISO 11135:2014 Part 1. The purpose of this validation is to verify the maintenance of the effectiveness of the validated ethylene oxide sterilization process. The subject devices present the same sterilization method already validated for the predicate devices in K163194 and K191191.
The acceptance criteria is SAL of 10° and the result of the validation is passed.
EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
● Steam Sterilization
The moist heat sterilization cycle (Dynamic air removal – 132 C, 3 mins, unwrapped) have been validated by the overkill method to a sterility assurance level (SAL) of 10° according to 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) and ISO 17665-2 (Sterilization of health care products -Moist heat – Part 2: Guidance on the application of ISO 17665-1). The subject devices present the same sterilization method already validated for the predicate devices in K163194. The acceptance criteria is SAL of 106 and the result of the validation is passed.
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Shelf Life
. Sealing Strength
The Sealing Strength test is based on ASTM F88 and the purpose of this test is to validated the packaging. The acceptance criteria is resistance between 1.5 N and 15 N for specimens with width of 15 ± 1 mm and the result of the test is passed.
● Dye Penetration
The Dye Penetration test is based on ASTM F1929 and the purpose of this test is to validated the packaging. The acceptance criteria is no dye solution leakage through the blister sealing and the result of the test is passed.
● Bubble Test
The Bubble test is based on the ASTM F2096 and the purpose of this test is to validated the packaging. The acceptance criteria is no constant flow of bubbles in the sealed area of the blister indicating a failure area and the result of the test is passed.
The subject devices present the same shelf life already validated for the reference predicate devices in K193592 - Change in the Shelf Life for Neodent Acqua Implants. The shelf life for the Easy Pack System is 4 years.
Biocompatibility
● Chemical Characterization
The Chemical Characterization is a test based on the ISO 10993-12 and ISO 10993-18 to identify extractable/leachable chemicals. The acceptance criteria is MOS > 1 or HI 1 or HI Bacterial Endotoxins Test by United States Pharmacopeia and ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Method, Routine Monitoring and Alternatives to Batch Testing.
The quantity of samples is defined by the two standards above. The reports are being provided within this submission.
MRI
The MRI test is based on ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119. The test has the purpose of characterization and behavior of the metallic implant system when subjected to the energy of a MRI scan. This study assesses magnetic migration, magnetic torsion, image aberration and RF-induced heating.
The acceptance criteria of each standard are as follow:
- . ASTM F2052: maximum deflection angle, measured at the entrance of the bore of a 3T MRI of 45°
- ASTM F2213: the maximum MR induced torque must be less than the maximum torque induced by the force of gravity
- . ASTM F2182: the mathematic model shall have a maximum deviation of ± 20% from the real measurement to confirm the model and the maximum temperature rise shall be less than 6°C.
- ASTM F2119: This test is for the purpose of characterization.
The results of the MRI is that a patient with an implant from a Straumann Group Implant System can be scanned safely in a MR System under the following conditions:
- Static magnetic field of 1.5T and 3T, only
- Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode. Under the scan conditions defined, the implants, as well as clinically relevant implant constructs, from a dental implant system of a Straumann Group company are expected to produce a maximum temperature rise of 4.9°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the implants from a dental implant system for a Straumann Group company extends approximately 10 mm from this device when imaged with a gradient echo pulse sequence and a 3T MR system.
The subject devices have been assessed to determine whether the previously conducted studies related to the MR compatibility of the devices of the Neodent Implant System also apply to the subject devices. It has been determined that the subject devices do not result in new worst-case constructs for the purpose of assessing MR compatibility and they can be leveraged from the preciously cleared K182620.
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Mechanical Tests
- . Torsion
The Torsion test is based on ISO/TS 13498:2011 and the purpose is to evaluate the static torsional loading. The acceptance criteria is 2.0 safety factor on the indicated torque on the IFU and the result of the test is passed.
. Insertion
The Insertion test is based on ASTM F1839-08 and the purposed is to evaluate the implant presents minimum insertion torque in different situations.
The complete reports regarding mechanical tests (Dynamic Fatigue Test, Torsion Test and Insertion Test) are being provided within this submission.
CONCLUSION
The subject devices and the predicate devices have equivalent Indications for Use, design and technological characteristics. Equivalent range of overall dimensions and sterilization methods. The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.