Who is the manufacturer of Axiom PX?

Anthogyr Sas filed the 510(k) submission for Axiom PX (K161177).

What is the FDA product code for Axiom PX?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Axiom PX?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Axiom PX?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Axiom PX

K161177 · Anthogyr Sas · DZE · Jun 15, 2017 · Dental

Device Facts

Record ID	K161177
Device Name	Axiom PX
Applicant	Anthogyr Sas
Product Code	DZE · Dental
Decision Date	Jun 15, 2017
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Axiom® PX is an endosseous dental implant system designed for replacement of missing teeth; functions as artificial root structure. Implants are surgically placed into upper or lower jaw; used for stabilization of removable prostheses or fixation of single tooth/partial dentures. System includes titanium implants (Ti6Al4V-ELI) with BCP® surface treatment and DLC-coated abutment screws. Operated by dental practitioners in clinical settings. Device provides mechanical foundation for prosthetic restorations; aids in functional and aesthetic integration. Performance validated via static/fatigue testing (ISO 14801), biocompatibility (ISO 10993), and sterilization validation (ISO 11137/17665).

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes static and fatigue biomechanical testing (ISO 14801), biocompatibility testing (ISO 10993 series: cytotoxicity, intracutaneous, sensitization, chemical characterization), surface analysis (SEM), and shelf-life validation (ASTM F1980, F1929-15, F88-15). Sterilization validated per ISO 11137 and ISO 17665.

Technological Characteristics

Material: Ti6Al4V-ELI titanium. Surface: BCP® (implants), DLC (screws). Dimensions: Ø3.4-5.2mm, lengths 6.5-18mm. Connection: Internal conical. Sterilization: Gamma irradiation. Standards: ISO 14801 (fatigue), ISO 10993 (biocompatibility), ISO 11137/17665 (sterilization), ASTM F1980 (shelf-life).

Indications for Use

Indicated for patients requiring replacement of missing teeth via artificial root structures; supports stabilization of removable prostheses or fixation of single tooth restorations/partial dentures; suitable for one-stage or two-stage surgery; immediate or delayed loading determined by practitioner based on clinical factors.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

AXIOM® REG (K131066)

Reference Devices

Anthogyr Dental Implant System: Axiom (K101913)
Amorphous diamond coated screw (K992538)

Related Devices

K141450 — AXIOM 2.8 · Anthogyr Sas · Sep 17, 2014
K173575 — OsteoReady Dental Implant System · Osteoready, LLC · Aug 17, 2018
K240966 — Prima Plus Conical Implant System · Keystone Dental, Inc. · Jul 9, 2024
K132125 — A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM · A.B. Dental Devices , Ltd. · Jan 21, 2014
K131066 — AXIOM REG · Anthogyr Sas · Feb 21, 2014

Submission Summary (Full Text)

{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) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.