(57 days)
Tomas-pins are temporary, enossal anchorage point for attachment of orthodontic appliances.
To provide a fixed anchorage point for attachments of orthodontic appliances.
tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin SD is self-drilling. The tomas-pin SD 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 from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.
The provided document is a 510(k) premarket notification summary for the Dentaurum tomas-pin (Temporary Orthodontic Micro Anchorage System). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study.
Instead, it relies on a comparison of the tomas-pin device to predicate devices based on:
- Intended Use: The tomas-pin has the same intended use as the predicate devices: "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."
- Material: The tomas-pin is made of Titanium Grade 5 (ASTM), which is similar to the Titanium and Titanium Alloy (ASTM F 136-98) used in the predicate devices.
- Design and Characteristics: The submission states that the tomas-pin has similar dimensions and characteristics to the predicate devices.
- Potential Adverse Effects: These are identified as identical to those of the predicate devices.
The conclusion drawn is that the tomas-pin is "substantially equivalent in design, material, intended use and function" to the listed predicate devices. There is no performance study described in this document to assess specific acceptance criteria for a new device's efficacy or accuracy.
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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 12, 2006 Contact: Dr. Thomas Lietz, R&D Director 510(k) Summary of Safety and Effectiveness
- (1) Identification of the Device: 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), Straumann Ortho (2) Implant (K982509), Nobel Biocare Implant 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 point for attachment of (3) orthodontic appliances.
- Description of the Device: tomas-pin micro screws (orthodontic micro implant) are anchorage elements made (4) of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin SD is self-drilling. The tomas-pin SD 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 from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.
Image /page/0/Figure/8 description: The image shows a diagram of a medical screw with labels pointing to different parts. The screw has a threaded body, a soft tissue sleeve, and a hex head. The diagram also shows a retention channel and a retention head with two slots.
Retention channel Thread Soft tissue sleeve Hex head
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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 currently available in the following sizes:
| Tomas-pin 08 (Order No. 302-008-00) | Tomas-pin 10 (Order No. 302-010-00) |
|---|---|
| Length of screw body: 8mm | Length of screw body: 10mm |
| Diameter: 1.2mm | Diameter: 1.2mm |
Indications for Use: (5) 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, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture 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. t
- Increased fibrous tissue response around the fracture site and/or the implant. .
- . Necrosis of bone.
- Inadequate healing. .
Apart from these adverse affects there are always possible complical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.
| (7) Safety and Effectiveness, comparisons to predicate devices: | |||
|---|---|---|---|
| -- | ----------------------------------------------------------------- | -- | -- |
| Device Name | Nobel BioCareImplant OrthodonticAnchor System | OsteoMedOrthodontic ScrewSystem | Jeil Medical Corp.Dual Top AnchorSystem Screws(various models) | Dentaurum, Inc.tomas-pin (TemporaryOrthodontic MicroAnchorage System) |
|---|---|---|---|---|
| DeviceClassificationName | 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 intendedto provide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. It is usedtemporarily and isremoved afterorthodontic treatmenthas been completed. | This device is used asan anchorage fororthodontic treatmentin the mouth. | This device is intendedto provide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. It is usedtemporarily and isremoved afterorthodontic treatmenthas been completed. | This device is intendedto provide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. It is usedtemporarily and isremoved afterorthodontic treatmenthas been completed. |
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| Screws are intendedfor single use only. | Screws are intendedfor single use only. Foruse in adults over theage of 12. | Screws are intended forsingle use only. | ||
|---|---|---|---|---|
| Single Use? | YES | YES | YES | YES |
| SuppliedSterile? | No comment | Non sterile, steamsterilize before use | Non sterile, steamsterilize before use | Sterile |
- Conclusion: In all reports, the tomas-pin (Temporary Orthodontic Micro Anchorage System) is the equivalent (8) of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse affects are identical to those of predicate devices. This device is manufactured from titanium, grade 5 (ASTM) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM 136-98) to this device are manufactured and sold around the world. This device is substantially equivalent in design, material, intended use and function to the products on the table above. These devices are certified by the notified body for CE.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles R. Bell Manager Operational & Marketing Support Dentaurum, Incorporated 10 Pheasant Run Newtown, Pennsylvania 18940
NOV - 9 2006
Re: K062733
Trade/Device Name: TOMAS SD Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZF Dated: September 12, 2006 Received: September 14, 2006
Dear Mr. Bell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Bell
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance 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 Division 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 Lin, 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
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Image /page/5/Picture/0 description: The image shows the logo for DENTAURUM INC. The logo consists of a stylized letter D above the company name. Below the company name is the address 10 PHEASANT RUN • NEWTOWN, PA 18940.
Indications For Use
510(k) Number:
Device Name:
TOMAS SD
Indications For Use:
To provide a fixed anchorage point for attachment of orthodontic appliances.
Prescription Use
(Part 21 CRF 801 Subpart D)
AND/OR
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)
Susan Kaser
(Division Sign-Of)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K662733
Page 2-1
215-968-2858 • 800-523-3946
FAX 215-968-0809 • 800-553-6389
www.dentaurum com
§ 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.