(89 days)
No
The summary describes a physical dental implant system and its materials, without mentioning any software, algorithms, or data processing that would indicate AI/ML. The performance studies focus on mechanical and biological properties.
Yes
The device is used to restore the patient's chewing function, which is a therapeutic purpose.
No
This device is a dental implant system designed for surgical and restorative applications to support prosthetic devices and restore chewing function. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components made of Titanium Alloy, including implants, cover screws, abutment fixation screws, and abutments. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, the TRATE Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical placement in the bone to support prosthetic devices and restore chewing function. This is a direct intervention on the patient's body.
- Device Description: The description details the physical components of the implant system (implants, abutments, screws) made of titanium alloy. These are physical devices implanted into the body.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The TRATE Dental Implant System is a surgical implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants:
TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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
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
Non-clinical product evaluation to demonstrate substantial equivalence includes:
- Dynamic fatigue testing according to ISO 14801
- Biocompatibility testing according to ISO 10993
- Surface analysis SEM & EDX-surface evaluation
- Bacterial endotoxin batch testing including Limulus amebocyte lysate (LAL) test will be conducted according to ANSI/AAMI ST72 on samples of water used in manufacturing on a bimonthly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of
§ 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 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.
Trate AG % Jorge Millan Regulatory Director Sigma Biomedical 7737 N University Drive, Suite 101 Tamarac, Florida 33321
Re: K220022
Trade/Device Name: TRATE Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 21, 2021 Received: January 5, 2022
Dear Jorge Millan:
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
lence determination does not mean that FDA
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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220022
Device Name TRATE DENTAL IMPLANT SYSTEM
Indications for Use (Describe)
TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with 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
Image /page/3/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, red, bold letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, bold font.
510(K) Summary
Submitter Information
| Submitter | TRATE AG
Seestrasse 58
H-8806 Bäch (Switzerland)
Phone: +41 44 202 1919
Fax:
+41 44 202 1920 |
|------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| Fax number | (305) 328-4511 |
| E-mail | sigmabiomedical@gmail.com |
| Date prepared: | April 4, 2022 |
Subject Device Name
| Trade/Proprietary Name: | TRATE Dental Implant System |
|---|---|
| Common or Usual Name: | Root-form Endosseous Dental Implants & Abutments |
| Regulation Number: | 21 CFR 872.3640 |
| Regulation Name: | Endosseous dental implants |
| Product Code: | DZE (Primary) |
| NHA (Additional) | |
| Class | II |
| Panel | Dental |
Predicate Devices
| Predicate Devices: | Primary Predicate:
A.B. Dental Devices Ltd., K162482 |
|--------------------|---------------------------------------------------------|
| | Reference devices:
A.B. Dental Devices Ltd., K132125 |
4
Image /page/4/Picture/0 description: The image shows the logo for TRATE Dental Implant System. The word "TRATE" is in large, red, bold letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, bold font. The logo is simple and professional.
Device Description:
The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants:
TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implant model:
ROOTFORM Dental Implant Diameters: 3.5 mm, 3.8 mm, 4.2 mm, 4.8 mm, 5.5 mm For each diameter, available lengths: 8 mm, 10 mm, 12 mm, 16 mm, 16 mm
Abutment models:
| Type of abutment | Diameter | Lengths |
|---|---|---|
| Gingiva formers (GFx, GFNx) | 4 mm, 5 mm | 0.5 mm - 7 mm |
| Anatomical straight (Ax, A1N) | 3.98 mm, 4.8 mm | 9.3 mm, 10.3 mm, 11.3 mm, 12.3 mm |
| Anatomical angled 15°, 25° (AxAxx) | 4.8 mm, 4.9 mm | 9 mm, 10 mm, 11 mm, 12 mm |
| Multi-unit straight (Mx, MSx) | 4 mm, 4.5 mm | 1 mm, 2 mm, 3 mm, 4 mm |
| Multi-unit angled 15° (MxAxx) | 4 mm | 1 mm, 2 mm, 3 mm, 4 mm |
| Cover screws/Abutment fixation screws | One size only | One size only |
Temporary Abutments
A gingiva former, called else as a healing cap or healing abutment that is screwed onto the top of the implant. Healing abutment placement is based on the surgical technique followed i.e., immediately placed during single stage surgical procedure or later at two-stage surgical protocol to guide the healing of soft tissue to replicate the contours and dimensions of natural tooth that is being replaced and to ensure access to the implant restorative platforms for impression and definitive abutment placement. In TRATE Dental Implant System available a few variations of gingiva formers: Regular gingiva formers and narrow gingiva formers.
Retained Abutments
An abutment is a component that is intermediate between the restoration and is retained to the implant by a screw. In TRATE system available are the following variations of abutments: Anatomical straight abutments (regular and narrow), anatomical angled abutments, multi-unit straight abutments (regular and narrow), multi-unit angled abutments.
5
Image /page/5/Picture/0 description: The image contains the logo for "TRATE Dental Implant System". The word "TRATE" is in large, bold, red letters. To the right of "TRATE" are the words "Dental Implant System" in a smaller, black, serif font.
Indications for Use:
TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Non-Clinical Data:
In support of substantial equivalence safety and performance testing has been conducted to evaluate biocompatibility, bacterial endotoxin levels, sterility levels, total organic content. Mechanical performance in terms of dynamic compression-bending testing was performed to support substantial equivalence. Dynamic testing was performed on worst-case subject device constructs. Non-clinical product evaluation to demonstrate substantial equivalence includes:
- Dynamic fatigue testing according to ISO 14801
- Biocompatibility testing according to ISO 10993 ●
- Surface analysis SEM & EDX-surface evaluation
- Bacterial endotoxin batch testing including Limulus amebocyte lysate (LAL) test will be . conducted according to ANSI/AAMI ST72 on samples of water used in manufacturing on a bimonthly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of