(415 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, and performance testing (sterilization, shelf-life, biomechanical, biocompatibility, surface analysis). There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device functions as an artificial root structure for replacing missing teeth and stabilizing dental prostheses, which are considered therapeutic applications aimed at restoring function and improving patient health.
No.
The device is a dental implant system used as an artificial root structure for the replacement of missing teeth, and for the stabilization of prostheses. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states the device is composed of physical components (implants and screws made of Ti6AI4V-ELI) and describes their dimensions and surface treatments. It also details performance studies related to sterilization, shelf-life, biomechanical testing, and biocompatibility, all of which are associated with physical medical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used as "artificial root structures for replacement of missing teeth." This is a surgical and prosthetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components (implants and screws) and their materials and dimensions. This aligns with a medical device used for implantation, not a diagnostic kit or instrument.
- Performance Studies: The performance studies focus on sterilization, shelf-life, biomechanical testing (static and fatigue), biocompatibility, and surface analysis. These are typical tests for implantable medical devices, not IVDs which would involve analytical and clinical performance studies related to measuring substances or detecting conditions.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted into the body for structural support.
N/A
Intended Use / Indications for Use
Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations.
The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants.
Implants:
Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.
Material: Ti6AI4V-ELI
Surface treatment: BCP®
Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm
Ø5.2, length 6.5, 8, 10, 12 mm
Screws:
Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI
Surface treatment: DLC
Dimensions: M1.4, length 5, 7.9 mm
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
practitioner
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)
Performance testing included:
- Sterilization validation: Gamma irradiation sterilization was conducted on a representative worst case implant in accordance with ISO 11137 series standards. Sterility was supported for the implants and DLC screws. Validation of cleaning and sterilization parameters for end-user sterilized products was done according to ISO 17665-1 and ISO 17665-2 for non-sterile DLC screws.
- Shelf-life validation: Validated according to ASTM F1980 under accelerated and real-time ageing, supporting sterility throughout shelf life. Dye penetration test (ASTM F1929-15), peeling testing, seal strength testing (ASTM F88-15), and sterility test were performed.
- Biomechanical testing: Static and fatigue testing conducted on a representative worst case scenario in air in accordance with ISO 14801 (2007) and Special Controls Guidance Document. Fatigue limit compared to predicate Axiom REG implants (K131066). Surface area analysis, insertion torque testing, and pullout strength testing included to demonstrate substantial equivalence.
- Biocompatibility testing: Performed according to ISO 10993 series standards for implants and abutment screws.
- Implants: Chemical characterization (ISO 10993-18:2005) and Cytotoxicity test (ISO 10993-5:2009).
- Abutment screws: Chemical characterization (ISO 10993-18:2005), Cytotoxicity test (ISO 10993-5: 2009), Intracutaneous study (ISO 10993-10:2010), and Sensitization study (ISO 10993-10:2010).
- Surface analysis: SEM for implants as required by FDA guidance.
Key Results:
- The mechanical testing shows that the performance of the Axiom PX implants is substantially equivalent to the predicate device.
- Based on technological characteristics, the Axiom PX implants have been shown to be substantially equivalent to the Axiom REG implants.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
ANTHOGYR SAS Therese Candau Regulatory Affairs Engineer 2237 Avenue Andre Lasquin Sallanches, 74700 FRANCE
Re: K161177
Trade/Device Name: Axiom® PX Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 12, 2017 Received: June 13, 2017
Dear Therese Candau:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -A
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161177
Device Name Axiom® PX
Indications for Use (Describe)
Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
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
SECTION 5 510(K) SUMMARY
Section 5 – page 1 / 7 510(k) summary
4
510(k) SUMMARY
SUBMITTER'S CONTACT INFORMATION 5.1
ANTHOGYR SAS
2237, avenue André Lasquin SALLANCHES, FRANCE 74700 Registration Number: 8020776 Phone number: (33) (0)4 50 58 02 37 Fax number: (33) (0)4 50 93 78 60 Contact person: Thérèse CANDAU (m.candau@anthogyr.com) Preparation date: 06/14/2017
5.2 DEVICE
Trade name: AXIOM® PX Classification name: Endosseous Dental Implant Class II Product Code: DZE / NHA CFR Section: 21CFR 872.3640 Device panel: DENTAL 510(k) Number: K161177
5.3 PREDICATE DEVICE
Primary Predicate Device
K131066, AXIOM® REG manufactured by Anthogyr for implants
Reference Predicate Device
K101913, Anthogyr Dental Implant System: Axiom manufactured by Anthogyr
K992538, Amorphous diamond coated screw manufactured by NobelBiocare for attachment screws
5
The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations.
The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants.
Implants:
Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.
Material: Ti6AI4V-ELI
Surface treatment: BCP®
Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm
Ø5.2, length 6.5, 8, 10, 12 mm
Screws:
Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI
Surface treatment: DLC
Dimensions: M1.4, length 5, 7.9 mm
INDICATIONS FOR USE 5.5
Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures.
Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
6
PERFORMANCE TESTING 5.6
ANTHOGYR AXIOM® PX conforms to Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff Document issued on May 12, 2004.
Sterilization validation
Gamma irradiation sterilization was conducted on a representative worst case implant in order to support sterility of the implants, in accordance with ISO 11137 series standards. Sterilization was performed on the predicate device (K131066).
Both implants and DLC screws are sold sterile.
Validation of the recommended cleaning and sterilization parameters for end-user sterilized products was conducted according to ISO 17665-1 and ISO 17665-2 to validate DLC screws sterilization when sold non sterile.
Shelf-life validation
The shelf-life has been validated in accordance with ASTM F1980 under accelerated and real-time ageing and supports that the product remains sterile throughout the shelf life. Dye penetration test (ASTM F1929-15), peeling testing, seal strength testing (ASTM F88-15) as well as sterility test were performed.
Biomechanical testing
Static and fatigue testing has been conducted on a representative worst case scenario in air in accordance with ISO 14801 (2007) and Special Controls Guidance Document : Root-form Endosseous Dental Implant and Endosseous Dental Abutments - Guidance for Industry and FDA Staff Document issued on May 12, 2004. The fatigue limit has been compared to the predicate Axiom REG implants fatique limit (K131066). Surface area analysis, insertion torque testing, and pullout strength testing has been included in this submission to demonstrate substantial equivalence.
Biocompatibility testing
Biocompatibility assessment has been performed according to ISO 10993 series standards for implants and abutment screws.
Implants:
Chemical characterization (ISO 10993-18:2005 – to determine the type and levels of extractable chemicals present).
7
Cytotoxicity test (ISO 10993-5:2009 - the cytotoxicity test is used to determine the biological response of mammalian cells in vitro by exposing mouse fibroblast cells after extraction).
Abutment screws:
Chemical characterization (ISO 10993-18:2005)
Cytotoxicity test (ISO 10993-5: 2009)
Intracutaneous study (ISO 10993-10:2010 - Intradermal injection of test extracts in the rabbit to evaluate the potential of the material to produce irritation).
Sensitization study (ISO 10993-10:2010 - to assess the contact sensitization potential of the device in the albino guinea pig after a polar and non-polar extraction).
Surface analysis
SEM for the implants as required by FDA guidance class II special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
TECHNOLOGICAL CHARACTERISTICS 5.7
5.7.1 Implants
| | Candidate
Axiom PX | Predicate
Axiom REG | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: Axiom PX | Image: Axiom REG | The thread of the PX
implant is different from
the REG implant in order
to easier the post-
extractional placement
and low-density bone |
| Material | Titanium: Ti6Al4V-ELI | Titanium: Ti6Al4V-ELI | Same material for both
implants |
| Indications
for use | Anthogyr dental implants
are intended for use as
artificial root structures
for replacement of missing
teeth. They can be used
for stabilization of
removable prostheses or
fixation of single tooth
restorations or partial
dentures.
Anthogyr dental systems
are indicated for one-
stage or two-stage | Anthogyr dental implants
are intended for use as
artificial root structures for
replacement of missing
teeth. They can be used for
stabilization of removable
prostheses or fixation of
single tooth restorations or
partial dentures.
The Axiom dental system is
indicated for one-stage or
two-stage surgery.
It is up to the practitioner | The indications for use
are the same for both
implants. The indications
for Axiom REG include
both implants and
prosthetic parts
indications.
The Axiom PX indications
include only the implants
indications as the
prosthetic parts are not
presented here. |
8
| | surgery.
It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading. | to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations. | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Compatible
abutments | Axiom REG Aesthetic
abutments
Axiom REG Standard
abutments
Axiom REG conical
abutments
Axiom REG Healing screws | Axiom REG Aesthetic
abutments
Axiom REG Standard
abutments
Axiom REG conical
abutments
Axiom REG Healing screws | Same compatible
abutments |
| Dimensions | Ø3.4 mm;
Length 8-18 mm
Ø4.0 mm;
Length 8-18 mm
Ø4.6 mm;
Length 6.5-14 mm
Ø5.2 mm;
Length 6.5-12 mm | Ø3.4 mm;
Length: 8-18 mm
Ø4.0 mm;
Length: 6.5-18 mm
Ø4.6 mm;
Length: 6.5-14 mm
Ø5.2 mm;
Length: 6.5-14 mm | The PX implants
dimensions available are
included in the range of
REG implants |
| Surgical
approach | One stage surgery
Two stages surgery
Immediate loading | One stage surgery
Two stages surgery
Immediate loading | The surgical approach is
the same |
| Surface
treatment | sand blasting BCP +
passivation | sand blasting BCP +
passivation | Same treatment surface
for both implants |
| Sterilization
method | Gamma radiation | Gamma radiation | Same sterilization
process for both
implants |
5.7.2 Abutment screws
| | Candidate
Axiom PX screw | Predicate
NobelBiocare | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium: Ti6Al4V-ELI | Titanium: Ti6Al4V-ELI | Both made from same
material |
| Indications
for use | Anthogyr dental implants
are intended for use as
artificial root structures for
replacement of missing
teeth. They can be used for
stabilization of removable
prostheses or fixation of
single tooth restorations or
partial dentures.
Anthogyr dental systems
are indicated for one-stage | The Amorphous Diamond
Coated Screw is used to
retain prosthetic
components to dental
implants or to other
prosthetic components. The
amorphous diamond
coating will add a greater
pre-load to the screw,
which in turn help prevent
the screw and prosthetic | The indication for the
predicate is specific to
the Diamond Coated
Screw, while the
indication for the
subject device
describes the entire
implant system,
including the Axiom PX
screw. |
9
| | or two-stage surgery.
It is up to the practitioner
to decide whether
immediate or delayed
loading is most appropriate,
based on clinical factors like
good primary stability and
appropriate occlusal
loading. | components from
loosening. | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Compatible
abutments | Axiom REG Aesthetic
abutments
Axiom REG Standard
abutments
Axiom REG conical
abutments | Pre-fabricated titanium
abutments compatible with
NobelActive implants | Each system has its
own compatible range |
| Connection
type | Internal conical connection | Internal conical connection | Both internal conical
connection |
| Surface
treatment | Diamond Like Carbon | Diamond Like Carbon | Both DLC surface
treatment |
| Sterilization
method | Delivered not sterile or
sterile with abutment | Delivered not sterile | Anthogyr screw can be
delivered sterile. The
sterilization method
has been validated |
5.8 CONCLUSION
ANTHOGYR AXIOM® PX is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. Non clinical performance testing according to special control demonstrate that ANTHOGYR AXIOM® PX is substantially equivalent to its predicate device.
The mechanical testing shows that the performance of the Axiom PX implants is substantially equivalent to the predicate device.
Based on technological characteristics included in this submission, the Axiom PX implants have been shown to be substantially equivalent to the Axiom REG implants.