(219 days)
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No
The document describes dental implants and their intended use, with no mention of AI or ML technology.
Yes
The device is described as an artificial root structure for endosseous implantation, intended to replace missing teeth and support prostheses, which are therapeutic functions.
No
This device is an implant system (artificial root structures, abutments, etc.) intended for endosseous implantation to replace missing teeth and support prostheses. Its function is reconstructive and supportive, not diagnostic.
No
The device description and intended use clearly describe physical implants and associated hardware components for dental procedures, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes dental implants and related components intended for surgical implantation into the jawbone to replace missing teeth and support prostheses. This is a surgical device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "endosseous implantation in the mandible and maxilla for use as an artificial root structure." This is a therapeutic and restorative purpose, not a diagnostic one.
Therefore, the Implanova® implants and associated components are not IVD devices.
N/A
Intended Use / Indications for Use
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 missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches in the Implanova® system including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Short implants (6mm) are intended for delayed loading.
All 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
All 3.0mm implants must be splinted if two or more are used adjacent to each other. The 3.0mm implants (except 8mm length) are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading, The 3.0mm implant with 8mm length is intended for delayed loading.
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 immediately loaded by the presence of the abutment, but the occlusal forces need to be controlled and restricted while osseointergration takes place.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.
The Implanova® TiTACH™ system is indicated as a removable attachment of a full arch prosthesis when used in pairs and for a partial arch prosthesis in pairs. Minimum of two attachments are indicated to secure a complete or partial denture on 2-6 implants. This prosthesis is removable by patients.
The Implanova® FRIDGE® is indicated as a fixed attachment of a full arch prosthesis when used with 6 implants. This prosthesis is fixed for patients and removable by dentists.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible and maxilla
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/0 description: The image contains 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.
Dental Evolutions Inc. % Raymond Kelly Consultant Arazy Group 3422 Leonardo Lane New Smyrna Beach, Florida 32168
September 30, 2021
Re: K210523
Trade/Device Name: Implanova Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 8, 2021 Received: September 9, 2021
Dear Raymond Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210523
Device Name Implanova
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Indications for Use (Describe)
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 missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches in the Implanova® system including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Short implants (6mm) are intended for delayed loading.
All 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
All 3.0mm implants must be splinted if two or more are used adjacent to each other. The 3.0mm implants (except 8mm length) are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading, The 3.0mm implant with 8mm length is intended for delayed loading.
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 immediately loaded by the presence of the abutment, but the occlusal forces need to be controlled and restricted while osseointergration takes place.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.
The Implanova® TiTACH™ system is indicated as a removable attachment of a full arch prosthesis when used in pairs and for a partial arch prosthesis in pairs. Minimum of two attachments are indicated to secure a complete or partial denture on 2-6 implants. This prosthesis is removable by patients.
The Implanova® FRIDGE® is indicated as a fixed attachment of a full arch prosthesis when used with 6 implants. This prosthesis is fixed for patients and removable by dentists.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Implanova
Indications for Use (Describe)
| Table 2- Implanova® Bone Level to Astra Tech Compatibility List | ||||
|---|---|---|---|---|
| Component Type | Astra Tech | |||
| Part # | Device Name | Manufacturer | Compatible Implanova® | |
| Bone Level Fixtures | ||||
| Healing Abutment | 22851 | TempDesign™3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Healing Abutment | 22853 | TempDesign™3.5/4.0 NI | Astra Tech | All* Bone Level Implants |
| Healing Abutment | 24281 | Temporary Abutment 3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Healing Abutment | 24280 | Temporary Abutment 3.5/4.0 NI | Astra Tech | All* Bone Level Implants |
| Abutment Screw | 24449 | Abutment Screw Design 3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Abutment | 24910 - 24916 | Direct Abutment™3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Abutment | 24917 - 24923 | Direct Abutment API™3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Abutment | 24893 - 24898 | 20° UniAbutment 3.5/4.0* | Astra Tech | All* Bone Level Implants |
| Abutment | 24899 - 24904 | 45° UniAbutment 3.5/4.0* | Astra Tech | All* Bone Level Implants |
| Abutment | 24905 - 24909 | Ball Abutment 3.5/4.0 | Astra Tech | All* Bone Level Implants |
| Abutment | 24268 - 24272 | Locator™ Abutment 3.5/4.0 | Astra Tech | All* Bone Level Implants |
*Implanova 3mm implants can be used only with straight abutments of compatible connections.
| 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) |
801 Subpart D) Use (Part 21 ಡಿಗ
☐ 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.