(170 days)
Not Found
No
The device description focuses on the mechanical properties and insertion method of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the treatment of tooth abnormalities in orthodontics and pre-prosthetics, which constitutes a therapeutic application.
No
The device description indicates it is an "enossal anchorage element" used as a "fixed anchorage point for attachments of orthodontic appliances" for "the treatment of tooth abnormalities." This describes a device used for treatment, not for identifying a condition or disease.
No
The device description clearly details a physical implantable screw made of titanium, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The tomas-pin is described as a temporary, enossal (within bone) anchorage element. It is a physical implant inserted into the bone.
- Intended Use: The intended use is to provide a fixed anchorage point for orthodontic appliances to treat tooth abnormalities. This is a mechanical function within the body.
- No Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
The tomas-pin is a surgical implant used for mechanical support in orthodontic treatment, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Tomas-pins are temporary, enossal anchorage elements for the treatment of tooth abnormalities in orthodontics and pre-prosthetics.
To provide a fixed anchorage point for attachments of orthodontic appliances.
Temporary Orthodontic Micro Anchorage
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, anchorage elements made or grade 5 thankin (orrroo), according to ASTM (American Society for Testing and Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene.
The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking.
The tomas-pins are available in the following sizes:
Tomas-pin 08 (Order No. 302-008-00)
Length of screw body: 8mm
Diameter: 1.2mm
Tomas-pin 10 (Order No. 302-010-00)
Length of screw body: 10mm
Diameter: 1.2mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For use in adults over the age of 12.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 872.3640 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
APR 1 5 2005
Dentaurum, Inc. 10 Pheasant Run • Newtown, PA 18940 USA Tel: 800-523-3946 • Fax: 215-968-0809 Dentaurum, Germany Postfach 440 • 75104 Pforzheim, Germany Tel: 011-49-7231-803511 · Fax: 011-49-7231-803340 Revised September 1, 2004 Contact: Dr. Thomas Lietz, R&D Director 510(k) Summary of Safety and Effectiveness
- Identification of the Device: (1) Proprietary-Trade Name: tomas-pin (Temporary Orthodontic Micro Anchorage System) ( Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Bone Screw
- Equivalent legally marketed devices: OsteoMed Orthodontic Screw System (K031936), Strauman Ortho (2) Equivalent legally mancies do roces. Socor Orthodontic Anchor System (K000643), and the Jeil Medical Corporation Dual Top Anchor System Screws (K033767) ...
- Indications for Use (intended use): Tomas-pins are temporary, enossal anchorage elements for the treatment of (3) tooth abnormalities in orthodontics and pre-prosthetics.
- Description of the Device: tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, (4) Description of the Device. comas pin miero sorts (6), according to ASTM (American Society for Testing and anchorage elements made or grade 5 thankin (orrroo), and serve as a temporary anchor for various orthodontic tooth Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene.
Image /page/0/Figure/9 description: The image shows a medical implant with several labeled parts. The implant has a retention channel, a soft tissue sleeve, and a hex head. The implant also has a thread and a retention head with two slots.
Picture: Retention channel Thread Soft tissue sleeve Hex head Retention head with two slots
1
The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking.
The tomas-pins are available in the following sizes:
| Tomas-pin 08 (Order No. 302-008-00)
Length of screw body: 8mm
Diameter: 1.2mm | Tomas-pin 10 (Order No. 302-010-00)
Length of screw body: 10mm
Diameter: 1.2mm |
| ------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
|---|
Other product specifications can be found in the "Instructions for Use and Product Brochure".
Indications for Use: (ട)
To provide a fixed anchorage point for attachments of orthodontic appliances.
- Potential Adverse Affects and Complications: (Common to all devices of this type) (6)
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection . Poor bone lormation, Osteoporosis, Ostobily of the device or premature loss of fixation with the bone, leading to nonunion.
- Migration, bending, fracture or loosening of the implant. .
- Metal sensitivity or allergic reaction to a foreign body. .
- Pain, discomfort or abnormal sensation, due to the presence of the device. .
- I am, disoomirers of assue response around the fracture site and/or the implant. .
- Necrosis of bone. .
- Inadequate healing. .
Apart from these adverse affects there are always possible complications of any surgical procedure such as, but not /spart from these adverse damage, and pain which may not be related to the implant.
Safety and Effectiveness, comparisons to predicate devices: (7)
| Device Name | Nobel BioCare
Implant Orthodontic
Anchor System | OsteoMed
Orthodontic Screw
System | Jeil Medical Corp.
Dual Top Anchor
System Screws
(various models) | Dentaurum, Inc.
tomas-pin (Temporary
Orthodontic Micro
Anchorage System) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | Implant, Endosseous,
Product Code DZE | Implant, Endosseous,
Product Code DZE | Implant, Endosseous,
Product Code DZE | Implant, Endosseous,
Product Code DZE |
| Applicant | Nobel BioCare | OsteoMed | Jeil Medical Corp. | Dentaurum, Inc. |
| 510(K) Number | (K000643) | (K031936) | (K033767) | (this submission) |
| Material | Titanium | Titanium Alloy | Titanium Alloy
(ASTM F 136-98) | Titanium Grade 5
(ASTM) |
| Intended Use | This device is intended
to provide a fixed
anchorage point for
attachment of
orthodontic appliances
to facilitate the
orthodontic movement
of teeth. It is used
temporarily and is
removed after
orthodontic treatment
has been completed. | This device is used as
an anchorage for
orthodontic treatment
in the mouth. | This device is intended
to provide a fixed
anchorage point for
attachment of
orthodontic appliances
to facilitate the
orthodontic movement
of teeth. It is used
temporarily and is
removed after
orthodontic treatment
has been completed. | This device is intended
to provide a fixed
anchorage point for
attachment of
orthodontic appliances
to facilitate the
orthodontic movement
of teeth. It is used
temporarily and is
removed after
orthodontic treatment
has been completed. |
2
| | Screws are intended
for single use only. | | Screws are intended
for single use only. For
use in adults over the
age of 12. | Screws are intended for
single use only. |
|----------------------|---------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------|
| Single Use? | YES | YES | YES | YES |
| Supplied
Sterile? | No comment | Non sterile, steam
sterilize before use | Non sterile, steam
sterilize before use | Sterile |
- Conclusion: In all reports, the tomas-pin (Temporary Orthodontic Micro Anchorage System) is the equivalent (8) Conclusion: In an reports, the tonlas-pill (Temporary Orthoterials and have similar dimensions and of currently marked devices. They are identical to those of predicate devices . This devices manufactured characteristics. Potential adverse are identical in this kind of bone screw. Similar device made from titanium in the device is from fitanium, grade > (ASTM) that is used guice are manufactured and solus cound the world. This device is ttianum alloy (AS I M 136-98) to mis uevice and function to the products on the table above. These devices are certified by the notified body for CE.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2005
Dr. Thomas Lietz R&D Director Dentaurum, Incorporated 10 Pheasant Run Newtown, Pennsylvania 18940
Re: K042965
Trade/Device Name: TOMAS Pin Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 6, 2005 Received: April 8, 2005
Dear Dr. Lietz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becalled by the device is substantially equivalent (for the relerenced above and have accommissure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, or to de roos and nortic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Ocoments , therefore, market the device, subject to the general approval appreation (11.11). The general controls provisions of the Act include controls provisions of the Fiel. - 110 Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements concerning your device in the Federal Register.
4
Page 2 - Dr. Lietz
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 Incan that I DA has made a autes and regulations administered by other Federal agencies. Of the Act of ally i ederal bakes are requirements, including, but not limited to: registration 1 ou must comply with an art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), abouting systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of other (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow Jourse of substantial equivalence of your device to a premarket nothloation. - The results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at the for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may volum of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Li Lu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number K042965:
Device Name: TOMAS pin
Indications For Use: Temporary Orthodontic Micro Anchorage
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
N/A Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Mulyton MSR
് സാനിലിന്റെയും General Hospitz. n Control, Dental Devices
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