(107 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is described as an artificial root structure for replacement of missing teeth, which is a restorative function, not a therapeutic one.
No
The device is an implant system (artificial root structures, implants, and abutments) used for the replacement of missing teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it concerns implants and abutments made of materials like Ti6Al4V and PEEK, which are physical hardware components.
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 implants are "intended for use as artificial root structures for replacement of missing teeth." This describes a surgical implant for structural support within the body.
- Device Description: The device description details the materials (Ti6Al4V, PEEK), dimensions, and function of dental implants and abutments, which are physical devices implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is the treatment (replacing a missing tooth root).
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component.
N/A
Intended Use / Indications for Use
ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.
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.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.
Product codes
DZE, NHA
Device Description
The AXIOM® 2.8 implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The implant-abutment combination can support occlusal charge without risk of damaging the restoration and will not generate hazardous peek of stress at the prosthetic interface level.
The file concerns the implants and abutments.
Implants:
Replacement of a missing root for placement of a dental restoration.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø2.8, length: 10-14 mm
Abutments:
Provide support for a single permanent restoration.
Material: Ti6Al4V
Dimensions: Ø2.8
Angle: 0-23°
Gingival height: 1-5.5 mm
Temporary abutments:
Provide support for a temporary restoration.
Material: PEEK
Dimensions:Ø2.8
Gingival height: 1-5.5 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular incisors and lateral maxillary incisors (dental implants)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Practitioner (dental professional)
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)
A fatigue testing according to the standard ISO 14801 (2007) has been performed.
Results demonstrate comparable mechanical properties to the predicate device. No clinical data has been presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Axiom® REG (K101913/K131066) manufactured by Anthogyr, NobelActive 3.0 (K102436) manufactured by Nobel Biocare, 3.0 mm Integra CP Implant (K101849) manufactured by Bicon, Sendax MDI and MDI PLUS (K031106) manufactured by Imtec
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
Anthogyr SAS Ms. Thérése Candau Regulatory Affairs Engineer 2237 Avenue Andre Lasquin Sallanches, France 74700
Re: K141450
Trade/Device Name: Axiom® 2.8 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 26, 2014 Received: September 3, 2014
Dear Ms. 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.
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Page 2 - Ms. Candau
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known): ___
Device Name: AXIOM® 2.8
Indications for Use:
ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.
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.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.
Prescription Use >I Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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SECTION 5 510(K) SUMMARY
4
510(k) SUMMARY
| ANTHOGYR SAS | |
|---|---|
| Submitter | 2237, avenue Andre Lasquin |
| SALLANCHES, FRANCE 74700 | |
| Registration Number: 8020776 | |
| Contacts | Ms. Thérèse CANDAU m.candau@anthogyr.com |
| Phone: (33) (0)4 50 58 02 37 Fax (33) (0)4 50 93 78 60 | |
| Regulatory: Dr. Isabelle DRUBAIX (PhD) IDEE CONSULTING | |
| idrubaix@nordnet.fr | |
| Trade Name | AXIOM® 2.8 |
| Classification Name | ENDOSSEOUS DENTAL IMPLANT |
| Class | II |
| Product Code | DZE / NHA |
| CFR section | 21CFR 872.3640 |
| Device panel | DENTAL |
| Legally marketed | |
| predicate devices | Axiom® REG (K101913/K131066) manufactured by Anthogyr |
| NobelActive 3.0 (K102436) manufactured by Nobel Biocare | |
| 3.0 mm Integra CP Implant (K101849) manufactured by Bicon | |
| Sendax MDI and MDI PLUS (K031106) manufactured by | |
| Imtec | |
| Description | The AXIOM® 2.8 implant system has been designed in order |
| to enhance the functional and aesthetic integration of implant | |
| supported restorations. The implant-abutment combination | |
| can support occlusal charge without risk of damaging the | |
| restoration and will not generate hazardous peek of stress at | |
| the prosthetic interface level. | |
| The file concerns the implants and abutments. | |
| Implants: | |
| Replacement of a missing root for placement of a dental | |
| restoration. | |
| Material: Ti6Al4V | |
| Surface treatment: BCP® | |
| Dimensions: Ø2.8, length: 10-14 mm | |
| Abutments: | |
| Provide support for a single permanent restoration. | |
| Material: Ti6Al4V | |
| Dimensions: Ø2.8 | |
| Angle: 0-23° | |
| Gingival height: 1-5.5 mm | |
| Temporary abutments: | |
| Provide support for a temporary restoration. | |
| Material: PEEK | |
| Dimensions:Ø2.8 | |
| Gingival height: 1-5.5 mm | |
| Indications for use | ANTHOGYR Axiom® implants are intended for use as artificial |
| root structures for replacement of missing teeth. They can be | |
| used for fixation of single tooth restorations. | |
| 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. | |
| Axiom® 2.8 implants are indicated for single replacement of | |
| mandibular incisors and lateral maxillary incisors in cases | |
| presenting a restricted mesiodistal space. | |
| The prosthetic components of the Axiom 2.8 product line are | |
| intended to ensure support for single crowns only. | |
| Performance data | ANTHOGYR AXIOM® 2.8 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. | |
| A fatigue testing according to the standard ISO 14801 (2007) | |
| has been performed. | |
| Results demonstrate comparable mechanical properties to the | |
| predicate device. No clinical data has been presented. | |
| Substantial | |
| equivalence | ANTHOGYR AXIOM® 2.8 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 Endosseous dental implant system AXIOM® 2.8 is | |
| as safe, as effective, and performs as safely and effectively as | |
| its predicate devices. | |
| Preparation date | August 8th, 2014 |
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