(239 days)
Not Found
No
The description focuses on the physical aligners and the manual process involving the dentist and dental laboratory for treatment planning and fabrication. There is no mention of automated analysis, algorithms, or learning processes.
Yes
The device is indicated for the "alignment of teeth during orthodontic treatment of malocclusion," which is a medical condition. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is used for the "alignment of teeth during orthodontic treatment of malocclusion," which is a treatment function, not a diagnostic one. While it uses a scan of the patient's dentition, this scan is for planning and fabricating the aligners, not for diagnosing a condition.
No
The device description clearly states the Dentti System is a series of clear plastic aligners, which are physical medical devices fabricated from plastic material. While software is used in the design process, the final product delivered to the patient is a physical object.
Based on the provided information, the Dentti System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Dentti System works directly on the patient's teeth to physically move them. It does not analyze any biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- The intended use is for the alignment of teeth during orthodontic treatment. This is a therapeutic and mechanical function, not a diagnostic one.
- The device description details a process of scanning the dentition, designing aligners, and fabricating them for physical application to the teeth. This is consistent with a medical device used for treatment, not an IVD used for diagnosis.
The Dentti System falls under the category of a medical device, specifically an orthodontic appliance.
N/A
Intended Use / Indications for Use
"The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion."
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scan of the patient's current dentition
Anatomical Site
Teeth/Dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
Functional Testing: No functional testing was required.
Performance Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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.
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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,
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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
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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) |
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510(k) Summary
Dentti System
| Submitter: | Martz Inc.
8421 Blue Heron Drive
Bakersfield, CA 93312 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mason W. Diamond, DDS
Texel Fortis, LLC
150 Levinberg Lane
Wayne, NJ 07470
Phone: 508-333-0108
Fax: 973-305-0213
masonwd@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) – K081960
Clear Image™ Aligners (Specialty Appliances Works, Inc.)
– K071970
ClearCorrect System (ClearCorrect LLC) – K113618 |
| Device Description: | 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. |
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.
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| Submitter:
Martz, Inc. | Dentti System
Premarket Notification: Traditional 510(k) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | 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. |
| Substantial Equivalence
Discussion: | The design, indications for use, material composition,
mechanism of action, and technological characteristics of
the Dentti System, were Substantially Equivalent to thoseof the Invisalign, Clear Image systems, and ClearCorrect
Systems (predicate devices).
Martz, Inc. has demonstrated that, based on the
established evidence presented in the table below, the
Dentti 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." |
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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 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | Orthodontic Plastic Bracket
(Sequential Aligners) | Orthodontic Plastic Bracket
(Sequential Aligners) | Orthodontic Plastic Bracket
(Sequential Aligners) | Orthodontic Plastic Bracket
(Sequential Aligners) |
| Regulation
Number | 872.5470 | 872.5470 | 872.5470 | 872.5470 |
| Product Code | NXC | NXC | NXC | NXC |
| Indications for
Use | "The Dentti System is
indicated for the alignment of
teeth during orthodontic
treatment of malocclusion." | "The Invisalign System is
indicated for the alignment of
teeth during orthodontic
treatment of malocclusion." | "The Clear Image™ Aligners
system in intended to correct
minor discrepancies in the
alignment of maloccluded
anterior teeth on patients with
permanent dentition (second
molars) by moving the teeth
with a progressive series of
clear thin thermoformed plastic
aligners, fabricated in stages to
gradually align the teeth over a
period of several months. The
aligners are completely
removable by the patient and
may be discontinued at any
time." | "The ClearCorrect System is
indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e.,
all second molars). The
ClearCorrect System positions
teeth by way of continuous
force." |
| Characteristic | Dentti System - K151965 | Invisalign System - K081960 | Clear Image™ Aligners -
K071970 | ClearCorrect System - K113618 |
| Mechanism of
Action | 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. | 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. | 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. | Alignment of teeth by sequential
use of preformed trays. |
| Software | Yes | Yes | No | Yes |
| Materials that
Contact the
Patient | Commonly used thermoformed
plastic material -
Thermoformed Polyurethane
(Zendura) | Commonly used thermoformed
plastic material | Commonly used thermoformed
plastic material
Thermoformed Polycarbonate | Commonly used thermoformed
plastic material - Thermoformed
Polyurethane (Zendura) |
| Aligner Design | 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. | Covers buccal, lingual and
occlusal surfaces of the teeth
like a custom tray. In addition,
attachments could be affixed to
the teeth to aid retention | Covers buccal, lingual and
occlusal surfaces of the teeth like
a custom tray. | Covers buccal, lingual and
occlusal surfaces of the teeth like
a custom tray. In addition,
attachments could be affixed to
the teeth to aid retention. |
| Single Use | Yes - Multiple use by the same
patient | Yes - Multiple use by the same
patient | Yes - Multiple use by the same
patient | Yes - Multiple use by the same
patient |
| Supplied Sterile | No | No | No | No |
| Biocompatibility | Established for commonly used
thermoformed plastic material | Established for commonly used
thermoformed plastic material | Established for commonly used
thermoformed plastic material | Established for commonly used
thermoformed 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 |
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Submitter: Martz, Inc.
Dentti System
Premarket Notification: Traditional 510(k)
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