OBS Anchorage Screw

K152297 · Bomei Co, Ltd. · OAT · Feb 9, 2016 · Dental

Device Facts

• Record ID: K152297
• Device Name: OBS Anchorage Screw
• Applicant: Bomei Co, Ltd.
• Product Code: OAT · Dental
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Device Story

Self-tapping, non-active, endosseous dental implant; used as fixed anchorage point for orthodontic/preprosthetic appliances. Input: manual surgical placement into bone by qualified dentist. Operation: provides mechanical stability for orthodontic force application. Output: fixed anchor point. Used in dental clinics. Benefits: facilitates controlled orthodontic tooth movement. Single-use; removed after treatment completion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: biocompatibility (ISO 10993-5, -10, -11), sterilization validation (ISO 11737, ISO 17665, AAMI/ANSI ST79), and mechanical performance testing (ASTM F543) comparing subject device to predicate devices.

Technological Characteristics

Non-active, self-tapping endosseous screw. Materials: Stainless steel (ISO 5832-1/ASTM F138-13) and Titanium alloy (ISO 5832-3/ASTM F136-13). Diameters: 1.5mm, 2.0mm. Lengths: 8-14mm. Head types: square collar mushroom (none/round/slot hole). Supplied non-sterile; steam sterilized (pre-vacuum, 132°C).

Indications for Use

Indicated for patients requiring orthodontic tooth movement; provides fixed anchorage for orthodontic appliances. Used temporarily and removed post-treatment. Professional use only by qualified dentists.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Syntec Orthodontic Mini Screws (K090476)
• Syntec Wetali Orthodontic Mini Screws (K142001)
• Absoanchor Microimplant (K060126)
• Leone orthodontic mini implant (K071490)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2016

Bomei Co., Ltd % Shaoyin Peng Official Correspondent 258 N Bay Dr. Bullard. Texas 75757

Re: K152297

Trade/Device Name: Obs Anchorage Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 29, 2015 Received: January 7, 2016

Dear Shaoyin Peng:

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.

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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 801and Part 809); 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K152297

Device Name

OBS Anchorage Screw

Indications for Use (Describe)

Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth.

It is used temporarily and is removed after orthodontic treatment has been completed.

| X Prescription Use (Part 21 CFR 801 Subpart D)<br>Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | | | | |
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Type of Use (Select one or both, as applicable)

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510(k) summary complying with 21 CFR 807.92.

- Submitter 1.
BOMEI CO., LTD.

Tel: [phone]

Fax:[phone]

Address: 4F, No 1492-2, Chunrih Rd., Taoyuan City, Taoyuan County, 33051 ,

Taiwan.

Contact Person: Linney Chiang

E-mail: [e-mail]

Date prepared: December 29 , 2015

- II. Device
Name of the device: OBS Anchorage Screw

Common or Usual Name: OBS Anchorage Screw

Product Type: OBS(BD)

Classification Name: Endosseous dental implant (21 CFR 872.3640)

Regulatory Class: II

Product Code: OAT

#### Predicate Device =

K090476(Primary Predicate), Syntec Orthodontic Mini Screws ,

Syntec Scientific Corporation

K142001(Reference Predicate), Syntec Scientific Corporation ,

Syntec Wetali Orthodontic Mini Screws

K060126(Reference Predicate), Absoanchor Microimplant , Dentos Inc K071490(Reference Predicate), Leone SpA , Leone orthodontic mini implant

- IV. Intended Use
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth.

It is used temporarily and is removed after orthodontic treatment has been completed.

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#### Device Description >

OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length.

- Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) .
- Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) .

There are three types of OBS Anchorage Screw.

- . Square collar mushroom head none hole
- . Square collar mushroom head round hole
- Square collar mushroom head slot hole .

OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.

The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated.

Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.

The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.

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#### VI. Table of Safety and Effectiveness Substantial Equivalence Comparison

| Device<br>Name | OBS Anchorage<br>Screw | Syntec<br>orthodontic mini<br>screws | Syntec Wetali<br>Orthodontic Mini<br>Screws | Absoanchor<br>Microimplant | Leone<br>orthodontic mini<br>implant | Length (mm) | 8 / 10 / 12 / 14 | 5-12 | 6-12 | 4 -10 & 12 | 6-12 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Applicant | BOMEI | Syntec Scientific<br>corporation<br>(Taiwan) | Syntec Scientific<br>corporation<br>(Taiwan) | Dentos Inc<br>(South Korea) | Leone SpA(Italy) | Diameter (mm) | 1.5 / 2 | 1.3-2 | 1.4-2 | 1.2-1.8 | 1.5-2 |
| 510(K)<br>Number | K152297 | K090476 | K142001 | K060126 | K071490 | Energy Sources | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices |
| Regulation<br>No. | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | Where used | Dental practices | Dental practices | Dental practices | Dental practices | Dental practices |
| Product<br>Code | OAT | OAT | OAT | DZE | OAT | Target population | Professional use only - qualified dentists.<br>Strictly reserved to specialized and trained users. | Professional use only - qualified dentists.<br>Strictly reserved to specialized and trained users. | Professional use only - qualified dentists.<br>Strictly reserved to specialized and trained users. | Professional use only - qualified dentists.<br>Strictly reserved to specialized and trained users.<br>head-left handed<br>screw<br>8.OMAS<br>mushroom | Professional use only - qualified dentists.<br>Strictly reserved to specialized and trained users. |
| Material | Stainless Steel<br>(ISO<br>5832-1:2007/<br>ASTM<br>F138-13) ;<br>Titanium Alloy<br>(ISO<br>5832-3:1996/<br>ASTM F136-13) | Stainless Steel<br>(ISO<br>5832-1:2007/<br>ASTM<br>F138-13) ;<br>Titanium Alloy<br>(ISO<br>5832-3:1996/<br>ASTM F136-13) | Stainless Steel<br>(ISO<br>5832-1:2007/<br>ASTM<br>F138-13) ;<br>Titanium Alloy<br>(ISO<br>5832-3:1996/<br>ASTM F136-13) | Titanium Alloy<br>(ISO<br>5832-3:1996/<br>ASTM F136-13) | Stainless Steel<br>(ISO<br>5832-1:2007/<br>ASTM F138-13) | | | | | | |
| Intended<br>Use | Temporary<br>anchorage<br>screws are<br>intended to<br>provide a fixed<br>anchorage point<br>for attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of the<br>teeth.<br>It is used<br>temporarily and<br>is removed after<br>orthodontic<br>treatment has<br>been completed. | The screws are<br>intended to<br>provide fixed<br>anchorage for<br>attachment of<br>orthodontic<br>appliances<br>intended to<br>facilitate the<br>orthodontic<br>movement of<br>teeth. They are<br>used temporarily<br>and are intended<br>to be removed<br>after orthodontic<br>treatment has<br>been completed.<br>The screws are<br>intended for<br>single use only. | The screws are<br>indicated for use<br>as a fixed<br>anchorage for<br>attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of<br>teeth. They are<br>used temporarily<br>and are<br>removed after<br>orthodontic<br>treatment has<br>been completed.<br>They are<br>intended for<br>single use only. | Provide a fixed<br>anchorage point<br>for attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of<br>teeth. | Provide a fixed<br>anchorage for<br>attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of the<br>teeth. It is used<br>temporarily in<br>the maxillary and<br>mandibular bone<br>and must be<br>removed after<br>orthodontic<br>treatment has<br>been completed. | | | | | | |
| Supplied<br>Sterile | Non-Sterile ;<br>Steam Sterilize<br>before use | Non-sterile ;<br>Steam sterilize<br>before use. | Non-sterile ;<br>Steam sterilize<br>before use. | Non-Sterile ;<br>Steam Sterilize<br>before use | Non-sterile.<br>It is<br>recommended to<br>sterilize with<br>steam autoclave<br>before use. | | | | | | |
| Type | Square collar<br>Mushroom head:<br>1.None hole<br>2.Round hole<br>3.Slot hole | The screws are<br>with or without a<br>0.65mm<br>diameter hold. | The screws are<br>with or without a<br>0.7mm<br>diameter hold. | 1.Small head<br>2.No head<br>3.Long head<br>4.Circle head<br>5.Fixation head<br>6.Bracket head<br>7. Bracket | 1.High Head<br>2.Low head | | | | | | |

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VII. Comparison Of Technological Characteristics With The Predicate Devices

OBS anchorage screws and predicate devices Syntec Orthodontic Mini Screws , Syntec Wetali Orthodontic Mini Screws , Absoanchor Microimplant , and Leone orthodontic mini implant are based on the following same technological elements.

- . Intended use
- . Material
- . The sterilization method
- Potential adverse effects .

The following technological differences exist between the subject and predicate devices.

- . The type
- The dimensions (the diameter and the length) .

VIII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing has been performed in accordance with ISO 10993-5 , ISO 10993-10 , ISO 10993-11.

- Cytotoxicity: ISO 10993-5 Biological evaluation of medical devices -- Part . 5: Tests for In Vitro cytotoxicity (Biocompatibility)

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- Sensitization and Irritation: ISO 10993-10 Biological evaluation of . medical devices - Part 10: Tests for irritation and skin sensitization (Biocompatibility)
- Systemic toxicity: ISO 10993-11 Biological evaluation of medical devices • Part 11: Tests for systemic toxicity. (Biocompatibility)

Sterilization validating testing has been performed in accordance with ISO 11737-1 , ISO 11737-2 and ISO 17665-1 , ISO 17665-2 , AAMI / ANSI ST79 for steam sterilization.

- ISO 11737-1 Sterilization Of Medical Devices Microbiological Methods . Part 1: Determination Of The Population Of Microorganisms On Product, 2ed. (Sterility)
- . ISO 11737-2 Sterilization Of Medical Devices - Microbiological Methods -Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process. (Sterility)
- . ISO 17665-1 Sterilization Of Health Care Products -- Moist Heat -- Part 1: Requirements For The Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices. (Sterility)
- . ISO 17665-2 Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ISO 17665-1. (Sterility)
- . AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities.

Mechanical Performance Testing has been performed with the predicate devices Syntec Orthodontic Mini Screws and Absoanchor Microimplant in accordance with ASTM F543 that used in comparative performance testing were performed to demonstrate substantial equivalence.

- . ASTM F543 Standard Specification And Test Methods For Metallic Medical Bone Screws.
The results of this testing indicate that OBS Anchorage Screw met acceptance criteria and is substantially equivalent to predicate devices.

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#### IX. Conclusion

In comparison to the legally marketed devices, OBS anchorage screw has the same device characteristics as the predicates devices , intended use, material and the sterilization method.

The differences between the subject device and the predicate devices are the type, the dimensions (the diameter and the length).

However, testing data such as biocompatibility and mechanical performance testing provided in the submission prove that these differences would not raise issues in performance.

Based on the information provided in this premarket notification BOMEI concludes that OBS anchorage screw is substantially equivalent to the predicate device as described herein.

Therefore no clinical testing was conducted.