(239 days)
The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Dentti System is a series of clear plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The Dentist will provide a scan of the patient's current dentition along with instructions for the treatment plan. The dental laboratory will generate a series of 3-D computer-designs of the modified dentition that the Dentist will review. Upon approval, the models will be generated and used to fabricate the sequential aligners according to the dentist's prescription. The aligners are fabricated from commonly used thermoformed polyurethane plastic material. The aligners are sent back to the Dentist, who then provides them to the patient, confirming the fit and design. Over a period of months, additional aligners will be provided sequentially to the patient by the Dentist to gradually move the selected teeth to the desired position. The Dentist will monitor the treatment from the moment the first aligner is delivered to when treatment is completed. The aligners are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicate devices.
This document is a 510(k) premarket notification for the Dentti System, an orthodontic plastic bracket (sequential aligner). The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with specific thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on a comparison of characteristics, materials, and intended use, rather than specific quantitative performance studies with predefined acceptance limits.
The table below summarizes the comparative information provided in the "Substantial Equivalence Comparison" on page 6 of the document. The "Reported Device Performance" here refers to the characteristics of the Dentti System as presented in comparison to its predicates.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Dentti System - K151965) |
|---|---|---|
| Device Classification Name | Orthodontic Plastic Bracket (Sequential Aligners) | Orthodontic Plastic Bracket (Sequential Aligners) |
| Regulation Number | 872.5470 | 872.5470 |
| Product Code | NXC | NXC |
| Indications for Use | Alignment of teeth during orthodontic treatment of malocclusion (similar to predicates, though Clear Image has more narrow scope of "minor discrepancies in the alignment of maloccluded anterior teeth") | "The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion." |
| Mechanism of Action | Basic mechanics follows same principles of conventional orthodontics; aligners apply force on teeth to produce tipping, rotation, extrusion, and intrusion forces. | Basic mechanics follows the same principles of conventional orthodontics. The aligners apply a force on the tooth. Therefore, the Sequential aligners can produce tipping, rotation, extrusion and intrusion forces. |
| Software | Yes (for most comparable predicates like Invisalign and ClearCorrect) | Yes |
| Materials that Contact the Patient | Commonly used thermoformed plastic material; specifically, Thermoformed Polyurethane (Zendura) as used in ClearCorrect. | Commonly used thermoformed plastic material - Thermoformed Polyurethane (Zendura) |
| Aligner Design | Covers buccal, lingual and occlusal surfaces of the teeth like a custom tray; may include space for attachments to aid retention. | Covers buccal, lingual and occlusal surfaces of the teeth like a custom tray. When using the modified tray design, space is left for so thin attachments could be affixed to the teeth to aid retention. |
| Single Use | Yes - Multiple use by the same patient (for all predicates) | Yes - Multiple use by the same patient |
| Supplied Sterile | No (for all predicates) | No |
| Biocompatibility | Established for commonly used thermoformed plastic material. | Established for commonly used thermoformed plastic material (specifically, states "The material used in the FDA-Cleared ClearCorrect System (K113618) is exactly the same as the material used in the Dentti aligners (K151967)"). No additional testing required due to established biocompatibility. |
| Worn at Night | Yes (for all predicates) | Yes |
| Rx or OTC | Rx (for all predicates) | Rx |
How the Device Meets Acceptance Criteria (Study/Evidence):
The device meets the "acceptance criteria" by demonstrating substantial equivalence to the predicate devices through a detailed comparison of:
- Design: The Dentti System's design as a series of clear plastic aligners that move teeth gently in small increments is presented as technologically identical to predicate systems (page 4).
- Indications for Use: The stated indications for use are explicitly compared and found to be similar to the predicate devices (page 6).
- Material Composition: The Dentti System uses the same thermoformed polyurethane material (Zendura) as the ClearCorrect System (K113618) predicate. This pre-established biocompatibility and material usage eliminate the need for new testing (page 4).
- Mechanism of Action: The mechanism (mild force application for tooth movement) is described as following the same principles as conventional orthodontics and the predicate devices (page 6).
- Technological Characteristics: Other characteristics such as software usage, aligner design (covering surfaces like a custom tray, with an option for attachments), single use by the patient, non-sterility, and Rx-only classification are all shown to be equivalent to the predicates (page 6).
The submission explicitly states on page 5: "No bench testing was warranted for this product because the scientific literature and similarity in design, materials and use to the predicate devices assure that the aligners are suitable for the specified intended use." This indicates that direct performance testing for acceptance criteria was not performed for the Dentti System due to its demonstrated substantial equivalence to already approved devices.
Based on the provided document, the following information is not applicable or not provided:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set data is provided, as the submission relies on substantial equivalence rather than new performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no new clinical or performance test set was used for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical or performance test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an orthodontic aligner, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is an orthodontic aligner, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices, against which the Dentti System demonstrated substantial equivalence.
8. The sample size for the training set:
Not applicable. No training set was used as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
Martz, Inc. c/o Dr. Mason Diamond Texel Fortis, LLC 150 Levinberg Lane Wayne, NJ 07470
Re: K151965
Trade/Device Name: Dentii System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: II Product Code: NXC Dated: February 8, 2016 Received: February 12, 2016
Dear Dr. Diamond:
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.
{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 (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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is a complex, looping design to the left of the name. Below the name and signature is the letter "S".
for 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
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151965
Device Name
Dentti System
Indications for Use (Describe)
"The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion."
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}------------------------------------------------
510(k) Summary
Dentti System
| Submitter: | Martz Inc.8421 Blue Heron DriveBakersfield, CA 93312 |
|---|---|
| Contact Person: | Mason W. Diamond, DDSTexel Fortis, LLC150 Levinberg LaneWayne, NJ 07470Phone: 508-333-0108Fax: 973-305-0213masonwd@aol.com |
| Date Prepared: | March 10, 2016 |
| Trade Name: | Dentti System |
| Classification Name: | Orthodontic Plastic Bracket (Sequential Aligner) |
| Regulation Number: | 21 CFR 872.5470 |
| Product Code: | NXC |
| Predicate Devices: | Invisalign System (Align Technologies, Inc) – K081960Clear Image™ Aligners (Specialty Appliances Works, Inc.)– K071970ClearCorrect System (ClearCorrect LLC) – K113618 |
| Device Description: | The Dentti System is a series of clear plastic aligners thatare used to replace traditional orthodontic wires andbrackets for the alignment of maloccluded or misalignedteeth. This series of aligners moves the teeth gently, andin small increments, from their original to their final treatedposition for improved dental alignment.The Dentist will provide a scan of the patient's currentdentition along with instructions for the treatment plan.The dental laboratory will generate a series of 3-Dcomputer-designs of the modified dentition that the Dentistwill review. Upon approval, the models will be generatedand used to fabricate the sequential aligners according tothe dentist's prescription. The aligners are fabricated fromcommonly used thermoformed polyurethane plasticmaterial. |
{4}------------------------------------------------
Premarket Notification: Traditional 510(k)
The aligners are sent back to the Dentist, who then provides them to the patient, confirming the fit and design. Over a period of months, additional aligners will be provided sequentially to the patient by the Dentist to gradually move the selected teeth to the desired position. The Dentist will monitor the treatment from the moment the first aligner is delivered to when treatment is completed. The aligners are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicate devices.
- Indications for Use: The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
- Functional Testing: No functional testing was required.
- Mechanism of Action: Mild force is applied to the teeth via intentional distortion of the plastics when the aligners are seated in the mouth. Progressive changes in tooth position are introduced with each subsequent aligner. The Dentist can adjust the aligners as needed. The aligners can be removed and discontinued, if necessary
Summary of Technological
Martz, Inc. manufactures the customized aligners based on Characteristics: models or scans, and a prescription sent to the company by the prescribing dentist. The models are made after the clinician has assessed the patient's teeth, designed a treatment plan, and taken the impressions.
- Biocompatibility: The material used for fabrication of the Dentti System is a commonly-used thermoformed polyurethane material, used in many dental appliances, including the ClearCorrect Svstem predicate(K113618). polyurethane material is commercially available in the U.S. and its biocompatibility has already been well established. The material used in the FDA-Cleared ClearCorrect System (K113618) is exactly the same as the material used in the Dentti aligners (K151967). In both cases, standard pressure/vacuum thermoforming units are used to fabricate the Dentti and ClearCorrect appliances. In both cases, the Zendura thermoformable sheet material is processed according to the manufacturer's instructions. Since the polyurethane and the process used in fabricating the Dentti aligners is the same as the predicate device, and since biocompatibility has already been established, no additional testing is required to demonstrate biocompatibility of the proposed device.
{5}------------------------------------------------
| Submitter:Martz, Inc. | Dentti SystemPremarket Notification: Traditional 510(k) |
|---|---|
| Performance Testing: | No bench testing was warranted for this product becausethe scientific literature and similarity in design, materialsand use to the predicate devices assure that the alignersare suitable for the specified intended use. |
| Substantial EquivalenceDiscussion: | The design, indications for use, material composition,mechanism of action, and technological characteristics ofthe Dentti System, were Substantially Equivalent to thoseof the Invisalign, Clear Image systems, and ClearCorrectSystems (predicate devices).Martz, Inc. has demonstrated that, based on theestablished evidence presented in the table below, theDentti System is Substantially Equivalent to the Invisalign,Clear Image and ClearCorrect System predicate devices,in terms of intended use, material composition,fundamental scientific technology, principles of operation,and basic design." |
{6}------------------------------------------------
Submitter: Martz, Inc.
Dentti System Premarket Notification: Traditional 510(k)
Substantial Equivalence Comparison
| Characteristic | Dentti System - K151965 | Invisalign System - K081960 | Clear Image™ Aligners -K071970 | ClearCorrect System - K113618 |
|---|---|---|---|---|
| DeviceClassificationName | Orthodontic Plastic Bracket(Sequential Aligners) | Orthodontic Plastic Bracket(Sequential Aligners) | Orthodontic Plastic Bracket(Sequential Aligners) | Orthodontic Plastic Bracket(Sequential Aligners) |
| RegulationNumber | 872.5470 | 872.5470 | 872.5470 | 872.5470 |
| Product Code | NXC | NXC | NXC | NXC |
| Indications forUse | "The Dentti System isindicated for the alignment ofteeth during orthodontictreatment of malocclusion." | "The Invisalign System isindicated for the alignment ofteeth during orthodontictreatment of malocclusion." | "The Clear Image™ Alignerssystem in intended to correctminor discrepancies in thealignment of maloccludedanterior teeth on patients withpermanent dentition (secondmolars) by moving the teethwith a progressive series ofclear thin thermoformed plasticaligners, fabricated in stages togradually align the teeth over aperiod of several months. Thealigners are completelyremovable by the patient andmay be discontinued at anytime." | "The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.,all second molars). TheClearCorrect System positionsteeth by way of continuousforce." |
| Characteristic | Dentti System - K151965 | Invisalign System - K081960 | Clear Image™ Aligners -K071970 | ClearCorrect System - K113618 |
| Mechanism ofAction | Basic mechanics follows thesame principles of conventionalorthodontics. The alignersapply a force on the tooth.Therefore, the Sequentialaligners can produce tipping,rotation, extrusion and intrusionforces. | Basic mechanics follows thesame principles of conventionalorthodontics. The alignersapply a force on the tooth.Therefore, the Sequentialaligners can produce tipping,rotation, extrusion and intrusionforces. | Basic mechanics follows thesame principles of conventionalorthodontics. The aligners applya force on the tooth. Therefore,the Sequential aligners canproduce tipping, rotation,extrusion and intrusion forces. | Alignment of teeth by sequentialuse of preformed trays. |
| Software | Yes | Yes | No | Yes |
| Materials thatContact thePatient | Commonly used thermoformedplastic material -Thermoformed Polyurethane(Zendura) | Commonly used thermoformedplastic material | Commonly used thermoformedplastic materialThermoformed Polycarbonate | Commonly used thermoformedplastic material - ThermoformedPolyurethane (Zendura) |
| Aligner Design | Covers buccal, lingual andocclusal surfaces of the teethlike a custom tray. When usingthe modified tray design, spaceis left for so thin attachmentscould be affixed to the teeth toaid retention. | Covers buccal, lingual andocclusal surfaces of the teethlike a custom tray. In addition,attachments could be affixed tothe teeth to aid retention | Covers buccal, lingual andocclusal surfaces of the teeth likea custom tray. | Covers buccal, lingual andocclusal surfaces of the teeth likea custom tray. In addition,attachments could be affixed tothe teeth to aid retention. |
| Single Use | Yes - Multiple use by the samepatient | Yes - Multiple use by the samepatient | Yes - Multiple use by the samepatient | Yes - Multiple use by the samepatient |
| Supplied Sterile | No | No | No | No |
| Biocompatibility | Established for commonly usedthermoformed plastic material | Established for commonly usedthermoformed plastic material | Established for commonly usedthermoformed plastic material | Established for commonly usedthermoformed plastic material |
| Characteristic | Dentti System - K151965 | Invisalign System - K081960 | Clear Image™ Aligners -K071970 | ClearCorrect System - K113618 |
| Worn at Night | Yes | Yes | Yes | Yes |
| Rx or OTC | Rx | Rx | Rx | Rx |
{7}------------------------------------------------
Submitter: Martz, Inc.
Dentti System
Premarket Notification: Traditional 510(k)
{8}------------------------------------------------
Submitter: Martz, Inc.
Dentti System
Premarket Notification: Traditional 510(k)
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.