(127 days)
No
The document describes a physical dental implant and its mechanical properties, materials, and compatibility with existing abutment systems. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device, Immediate Molar Dental Implants, is designed for surgical placement in the jaw to provide a means for prosthetic attachment, restore chewing function, and retain overdentures, all of which are actions aimed at treating or alleviating a medical condition or restoring a body function.
No
Explanation: The provided text describes Immediate Molar Dental Implants, which are surgical devices intended for placement in the jaw to support dental prosthetics. Their function is to provide a means for prosthetic attachment and restore chewing function, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical dental implant made of titanium, packaged and sterilized. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for placement in the jaw to support dental prosthetics. This is a direct medical intervention on the patient's body.
- Device Description: The device is a physical implant made of titanium, designed to be surgically placed.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used for testing blood, urine, tissue samples, etc.
This device falls under the category of a medical device, specifically a dental implant.
N/A
Intended Use / Indications for Use
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
Abutment System Name: Abutments manufactured by Terrats Medical SL, Models: Titanium Abutments, Platform Diameters: 4.1, 5.0 and 5.7mm
Abutment System Name: Abutments manufactured by Zfx GmbH, Models: Titanium Abutments, Platform Diameters: 4.1, 5.0 and 5.7mm
Product codes
DZE
Device Description
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw, Maxillary or mandibular molar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The worst-case comparison for the subject devices have demonstrated substantially equivalent to K213672 and K220978 with regard to fatigue mechanical performance. MR compatibility testing to support the MR conditional labeling is leveraged from K150571, where testing was conducted on the worst case cleared Biomet 3i device constructs. Pull out tests and surface area analyses of the short implants with implantable thread length less than 7mm) demonstrated that the subject device is substantially equivalent to the reference device T3 Shorts (K150571). The Immediate Molar Implants possess the same multi-level surface topography by reference to K213672, which consist of surface treatments in the form of grit blasting with Calcium Phosphate (CaP) media per ASTM F1185 followed by the well-established dual acid etching process. The subject devices do not introduce a new worst-case.
Non-clinical data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstration a sterility assurance level (SAL) of 10-6, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K213672 demonstrating a shelf life of five years.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K213672, K220978, K013227, K150571, K210523, K191054
Reference Device(s)
K220978, K013227, K150571, K210523, K191054
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
October 23, 2024
Biomet 3i, LLC Krupal Patel Regulatory Affairs Principal 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K241753
Trade/Device Name: Immediate Molar Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 18, 2024 Received: September 19, 2024
Dear Krupal Patel:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: K241753
Device Name: Immediate Molar Implants
Indications for Use:
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured by | ||
| Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by | ||
| Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Part 21 CFR 801 Subpart D) and/or
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Product Evaluation and Quality (OPEQ)
4
Immediate Molar Implants 510(k) Summary 21 CFR 807.92 23-Oct-2024
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
I. Submitter Information:
| Name: | Biomet 3i LLC |
|---|---|
| Address: | 4555 Riverside Drive |
| Palm Beach Gardens, Florida 33410 | |
| Phone: | (561) 776-6923 |
| Fax: | (561) 514-6316 |
| Contact Person: | Krupal Patel |
|---|---|
| Job Title: | Principal Regulatory Specialist |
| Email: | krupal.patel@zimvie.com |
- II. Proprietary Trade Name: Immediate Molar Implants
- III. Device Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
- IV. Regulatory Class: Class II
- V. Product Code: DZE
VI. Predicate Devices:
Primary Predicate Device:
-
T3 PRO Implants (K213672)
Reference Predicate Devices: -
. TSX Implants (K220978)
-
Tapered Screw Vent Implants (K013227)
-
3i T3 Short Dental Implants (K150571) ●
-
Implanova (K210523)
-
. Southern Implants MAX Implant System (K191054)
VII. Product Description:
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is
5
packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
VIII. Indications for Use:
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured by | ||
| Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by | ||
| Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
6
IX. Summary of the Technological Characteristics:
The Immediate Molar Implant devices are identical to the predicate devices listed below in terms of operating principle and material. The subject device Indications for Use adds language for immediate implant placement to reflect the information that was included for the reference predicate device labeling which includes immediate implant placement. The technological characteristics such as length, connection & platform geometry, and the mating abutments are identical as the predicate devices. The subject device features a tapered design with a similar screw-type design and thread form as the predicate device. Like the primary predicate device, Immediate Molar Implant are manufactured out of commercially pure titanium per ASTM F67. The primary change from the predicate devices is implant diameter and thread form. Also, Immediate Molar Implant are offered in platform switched design only.
A substantial equivalence comparison of subject and predicate device is provided in table below.
7
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended
Use/
Indications
for Use | Immediate Molar
Dental Implants are
intended for surgical
placement in the
upper or lower jaw
to provide a means
for prosthetic
attachment in single
tooth restorations
and in partially or
fully edentulous
spans with multiple
single teeth utilizing
delayed loading, or
with a terminal or
intermediary
abutment for fixed or
removable
bridgework, and to
retain overdentures.
Immediate Molar
Dental Implants may
also utilize
immediate loading
for these indications.
Immediate Molar
Dental Implants are
intended for
immediate function | The T3 Pro Dental
Implants are intended
for surgical placement
in the upper or lower
jaw to provide a means
for prosthetic
attachment in single
tooth restorations and
in partially or fully
edentulous spans with
multiple single teeth
utilizing delayed or
immediate loading, or
as a terminal or
intermediary abutment
for fixed or removable
bridgework, and to
retain overdentures.
The T3 Pro Implants
may also utilize
immediate loading for
these indications. The
T3 Pro Implants are
intended for immediate
function on single tooth
and/or multiple tooth
applications when good
primary stability is
achieved, with | The TSX Implants are
designed for use in
the maxilla or
mandible for
immediate loading or
for loading after a
conventional healing
period. Implants may
be used to replace one
or more missing
teeth. Immediate
loading is indicated
when there is good
primary stability and
an appropriate
occlusal load.
Implants may be
placed immediately
following an
extraction or loss of
natural teeth provided
there is sufficient
volume of alveolar
bone to minimally
support the implant
(minimum 1mm
circumferential and
2mm apical) and
provide good primary
stability. | The Tapered Screw-
Vent and Screw-Vent
Implants are intended
for surgical
implantation in
edentulous mandibles
or maxillae for
attachment of
complete denture
prostheses, or as a
terminal or
intermediary
abutment for fixed or
removable
bridgework, or as a
freestanding single
tooth replacement. | The 3i T3 Short are
intended for surgical
placement in the
upper or lower jaw to
provide a means for
prosthetic attachment
in single tooth
restorations and in
partially or fully
edentulous spans
with multiple single
teeth utilizing
delayed loading, or
with a terminal or
intermediary
abutment for fixed or
removable
bridgework, and to
retain overdentures. | The Implanova®
implants are intended
for endosseous
implantation in the
mandible and maxilla
for use as an artificial
root structure. These
root form implants
can be used to
replace single or
multiple teeth
missing teeth and/or
to support a fixed or
removable prosthesis
in partially or
completely
edentulous upper and
lower dental arches.
Implanova® All-in-
One™ implants are
indicated to be used
when primary
stability of the
implant allows
presence of an
abutment at the time
of placement.
Implanova® All-in-
one™ are | Southern Implants
MAX implant is
intended for
implantation in
maxillary or
mandibular molar
region where bone
exists and the
surgeon has
determined that the
placement of a
narrower diameter
implant would
increase the
probability of failure
due to poor primary
stability, or increased
surgical procedures
leading to
complications. This
MAX implant
provides support for
fixed or removable
dental prostheses in a
single tooth, partially
edentulous prostheses
or full arch
prostheses. It further
adds the option for
immediate loading on | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| on single tooth
and/or multiple tooth
applications when
good primary
stability is achieved,
with appropriate
occlusal loading, in
order to restore
chewing function.
The Immediate
Molar Dental
Implants may be
placed immediately
following an
extraction or loss of
natural teeth
provided there is
sufficient volume of
alveolar bone to
provide good
primary stability.
The Immediate
Molar Dental
Implants are
intended for
implantation in the
maxillary or
mandibular molar
region where bone
exists and the
surgeon has
determined that the | appropriate occlusal
loading, in order to
restore chewing
function. | The 3.1mmD TSX
Implants should be
splinted to additional
implants when used in
the pre-molar region
and should not be
used in the molar
region. | | | immediately loaded
by the presence of the
abutment, but the
occlusal forces need
to be controlled and
restricted while
osseointegration
takes place. | single and splinted
multiple unit
restorations when
good primary
stability is achieved
and with appropriate
occlusal loading, to
restore chewing
function. | | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| | placement of a
narrower diameter
implant would
increase the
probability of
failure due to poor
primary stability, or
increased surgical
procedures leading
to complications.
The Immediate
Molar Dental
Implants are also
compatible with
titanium abutments
manufactured by
Terrats Medical S.L.
and Zfx GmbH | | | | | | | | | | | | | | | | |
| Operating
Principle | The Immediate
Molar Dental
Implants achieve
their intended
purpose based upon
their macro design
features, which
maximize primary
stability at time of
placement. | The T3 Pro Dental
Implants achieve their
intended purpose based
upon their macro
design features, which
maximize primary
stability at time of
placement. | The TSX Dental
Implants achieve
their intended
purpose based upon
their macro design
features, which
maximize primary
stability at time of
placement. | The Tapered Screw
Vent Dental Implants
are placed into a
prepared osteotomy
and once stability is
achieved; the implant
is restored with a
compatible
restorative device. | The 3i T3 Short
Dental Implants are
placed into a
prepared osteotomy
and once stability is
achieved, the implant
is restored with a
compatible
restorative device. | The Implanova
Dental Implants are
placed into a
prepared osteotomy
and once stability is
achieved, the implant
is restored with a
compatible
restorative device. | The Southern Max
Dental Implants are
placed into a
prepared osteotomy
and once stability is
achieved, the implant
is restored with a
compatible
restorative device. | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| Fundamental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | | | | | | | | | | |
| Scientific | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | | | | | | | | | | |
| Technology | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | | | | | | | | | | |
| Material | Commercially Pure
Titanium (CP4)
Per ASTM F67 | Commercially Pure
Titanium (CP4)
Per ASTM F67 | Titanium Alloy (Ti-
6Al-4V ELI) per
ASTM F136 | Titanium Alloy (Ti-
6Al-4V ELI) per
ASTM F136 | Commercially Pure
Titanium (CP4)
Per ASTM F67 | Titanium Alloy
(ASTM F136) | Commercially Pure
Titanium (CP4)
Per ASTM F67 | | | | | | | | | | |
| Implant
Body
Diameter
Range | Ø7.0mm, 8.0mm,
and 9.0mm | Ø3.25mm, 4mm,
5.0mm and 6.0mm | Ø3.1mm, 3.7mm,
4.1mm, 4.7mm,
5.4mm and 6.0mm | Ø3.7mm, 4.7mm and
6.0mm | Ø5.0mm and 6.0mm | Ø6.5, 7.5 and 8.5mm | Ø6.0mm, 7.0mm,
8.0mm and 9.0mm | | | | | | | | | | |
| Seating
Platform
Diameter | Subject T3 PRO
Immediate Molar
Implant: Ø6.0mm
Subject TSX
Immediate Molar
Implant: Ø5.7mm | Ø3.4mm, 4.1mm,
5.0mm
and 6.0mm | Ø2.9mm, 3.5mm and
4.5mm | Ø3.5mm, 4.5mm and
5.7mm | Ø5.0mm and 6.0mm | Ø6.5mm | Ø4.5mm, 5.5mm,
5.7mm, 6.5mm and
7.5mm | | | | | | | | | | |
| Implant
Length | Subject T3 PRO
Immediate Molar
Implant:
8.0mm, 10.0mm and
11.5mm
Subject TSX
Immediate Molar | 8.5mm, 10mm,
11.5mm, 13.0mm and
15mm | 8.0mm, 10mm,
11.5mm, 13.0mm and
16mm | 8.0mm, 10.0mm,
13.0mm and 16.0mm | 5.0mm and 6.0mm | 6.0mm, 8.0mm and
10.0mm | 6.0mm, 7.0mm,
9.0mm and 11.0mm | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| | Implant:
6.0mm, 8.0mm,
10mm, and 11.5mm
(Note: 6.0mm length
option is not
available for the
9mmD diameter
option of TSX
Immediate Molar
Implants) | | | | | | | | | | | | | | | | |
| Platform
Geometry | Platform Switched
only | Platform Switched and
Non-Platform Switched
Implants | Platform Switched
only | Platform Switched
only | Non-Platform
Switched Implants | Platform Switched
only | Platform Switched
only | | | | | | | | | | |
| Internal
External
Geometry
Design | Tapered only | Tapered only | Tapered only | Tapered only | Parallel Walled only | Tapered only | Tapered only | | | | | | | | | | |
| Implant
Connection | Subject T3 PRO
Immediate Molar
Implant:
Biomet 3i Internal
Hex (Certain®
Connection)
Subject TSX
Immediate Molar | Biomet 3i Internal Hex
(Certain® Connection) | 2.1mm, 2.5mm Hex
with Friction Fit | 2.5mm, 3.0mm Hex
with Friction Fit | External Hex | Internal
Hexagon | External Hex
Tri-lobe
Internal Hex | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| | Implant:
3.0mm Hex with
Friction Fit | | | | | | | | | | | | | | | | |
| Surface
Finish | • Grit Blasted with
Calcium
Phosphate (CaP)
• Dual-acid Etching
(OSSEOTITE®) | • Grit Blasted with
Calcium Phosphate
(CaP)
• Dual-acid Etching
(OSSEOTITE®) | Contemporary hybrid
surface: Osseotite
Dual Acid Etching
surface from the
coronal surface to
approximately 1.5mm
down the implant
collar, followed by
MTX Grit Blast using
Hydroxyapatite blast
media. | Single stage surface:
MTX Grit Blast using
Hydroxyapatite blast
media | • Grit Blasted with
Calcium
Phosphate (CaP)
• Dual-acid Etching
(OSSEOTITE®) | Resorbable
Blast Texture
Media (Calcium
Phosphate) | Grit-blasted | | | | | | | | | | |
| Anodized
Platform
Surface
Color | Subject T3 PRO
Immediate Molar
Implant: Green
Subject TSX
Immediate Molar
Implant: None | Purple, Blue, Yellow
and Green | None | None | Yellow and Green | None | None | | | | | | | | | | |
| Mating
Components | Subject T3 PRO
Immediate Molar
Implant: | Biomet 3i Internal Hex
Connection
Restorative
Components | Zimmer Dental TSV
Internal Connection
Restorative
Components, except | Zimmer Dental TSV
Internal Connection
Restorative
Components | Biomet 3i External
Hex Connection
Restorative
Components | Straight type
abutments, straight
type abutment screws
and straight type | Southern Implants
Restorative
Components with
external hex, tri-lobe | | | | | | | | | | |
| Feature | Subject Device
Immediate Molar
Dental Implants | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) | | | | | | | | | | |
| | Biomet 3i Internal
Hex Connection
Restorative
Components
(Compatible with
4.1mm, 5.0mm and
6.0mm connection);
and titanium
abutments
manufactured by
Terrats Medical SL
and Zfx GmbH. | | for the Zirconia based
abutments | | | temporary abutments
that are intended to
be on Astra Tech's
OsseoSpeed™ TX
3.5S and
OsseoSpeed™ TX
4.0S implant fixtures. | and internal hex
interface | | | | | | | | | | |
| | | | Subject TSX
Immediate Molar
Implant:
Zimmer Dental TSV
Internal Connection
Restorative
Components
(Compatible with
5.7mm connection);
and titanium
abutments
manufactured by
Terrats Medical SL
and Zfx GmbH. | | | | | | | | | | | | | | |
| | | | Feature | | | | Subject Device
Immediate Molar
Dental Implants | | | | | Primary Predicate
Device
T3 PRO Dental
Implants (K213672) | Reference Predicate
Device
TSX Dental Implants
(K220978) | Reference Predicate
Device
TSV Dental Implants
(K013227) | Reference Predicate
Device
3i T3 Short Dental
Implants (K150571) | Reference Predicate
Device
Implanova
(K210523) | Reference Predicate
Device
Southern Implants
MAX Implant
System (K191054) |
| | | | | | | | | | | | | | | | | | |
| | | | Sterilization
Method | | | | Supplied Sterile
(Gamma radiation) | | | | | Supplied Sterile
(Gamma radiation) | Supplied Sterile
(Gamma radiation) | Supplied Sterile
(Gamma radiation) | Supplied Sterile
(Gamma radiation) | Supplied Sterile
(Gamma radiation) | Supplied Sterile
(Gamma radiation) |
| | | | Shelf Life | | | | 5 years | | | | | 5 years | 5 years | 5 years | 5 years | 5 years | 5 years |
| | | | Single Use | | | | Yes | | | | | Yes | Yes | Yes | Yes | Yes | Yes |
Table 1: Substantial equivalence table
8
9
10
11
12
13
14
15
X. Non-Clinical Testing:
The worst-case comparison for the subject devices have demonstrated substantially equivalent to K213672 and K220978 with regard to fatigue mechanical performance. MR compatibility testing to support the MR conditional labeling is leveraged from K150571, where testing was conducted on the worst case cleared Biomet 3i device constructs. Pull out tests and surface area analyses of the short implants with implantable thread length less than 7mm) demonstrated that the subject device is substantially equivalent to the reference device T3 Shorts (K150571). The Immediate Molar Implants possess the same multi-level surface topography by reference to K213672, which consist of surface treatments in the form of grit blasting with Calcium Phosphate (CaP) media per ASTM F1185 followed by the well-established dual acid etching process. The subject devices do not introduce a new worst-case.
Non-clinical data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstration a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K213672 demonstrating a shelf life of five years.
There is a contractual agreement with Terrats Medical SL to support compatibility of Immediate Molar Implants for use with their Titanium abutments, without needing reverse engineering analysis testing. Zfx GmbH is a wholly owned subsidiary of ZimVie, which is also the parent company of Biomet 3i LLC. Engineering drawings are shared between Biomet 3i LLC and Zfx GmbH to support compatibility of Immediate Molar Implants for use with their Titanium abutments, without needing reverse engineering analysis testing.
The subject devices will not be labeled as non-pyrogenic or pyrogen-free, nor will any claims be made in regards to non-pyrogenicity.
No clinical data were included in this submission.
XI. Conclusion:
The subject devices have demonstrated substantial equivalence to the predicate devices in that they utilize same materials and fundamental designs and also have the same intended use and principles of operation.