Who is the manufacturer of BIO-RAY A-1 Anchor Screw System?

Microware Precision Co., Ltd. filed the 510(k) submission for BIO-RAY A-1 Anchor Screw System (K182929).

What is the FDA product code for BIO-RAY A-1 Anchor Screw System?

OAT. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for BIO-RAY A-1 Anchor Screw System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BIO-RAY A-1 Anchor Screw System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIO-RAY A-1 Anchor Screw System

Q: What are the predicate devices for BIO-RAY A-1 Anchor Screw System?

Syntec Orthodontic Mini Screws (K090476).

K182929 · Microware Precision Co., Ltd. · OAT · Nov 6, 2019 · Dental

Device Facts

Record ID	K182929
Device Name	BIO-RAY A-1 Anchor Screw System
Applicant	Microware Precision Co., Ltd.
Product Code	OAT · Dental
Decision Date	Nov 6, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.

Device Story

BIO-RAY A-1 Anchor Screw System provides fixed orthodontic anchorage; facilitates tooth movement. Device consists of stainless steel (316L) or titanium alloy (Ti-6Al-4V) screws; features self-drilling and self-tapping tips for insertion/removal. Head designs include mushroom, hook, or none for appliance attachment. Used in clinical orthodontic settings; operated by orthodontists. Screws are non-sterile; require steam sterilization before use. Output is mechanical anchorage point; enables application of orthodontic forces via coil springs, elastic chains, or rubber bands. Benefits patient by providing stable anchor for complex tooth movements.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing per ASTM F543, including self-tapping, torsional, axial pullout, driving torque, and shear loading tests. Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/reactivity), ISO 10993-11 (acute systemic toxicity), USP39/NF34(151) (pyrogenicity), and ISO 10993-6 (implantation).

Technological Characteristics

Materials: Stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Surface treatment: Electrolytic polishing (SS) or anodizing (Ti). Design: Self-drilling/self-tapping screw tip; various head types (mushroom, hook, none). Dimensions: 1.5-2.0mm diameter; 8-17mm length. Sterilization: Steam sterilization (non-sterile as provided).

Indications for Use

Indicated for patients requiring fixed anchorage to facilitate orthodontic tooth movement; intended for temporary use and removal post-treatment; single-use only.

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)

Reference Devices

Storm Mini Screw (K122069)
Absoanchor Microimplant (K060126)
Lin/Liou Orthodontic Mini Anchor System (Lomas) (K050257)
Tandry Locking Plate System (K171904)

Related Devices

K202163 — Mico One Orthodontic Screw · Ze Fang Technology Co., Ltd. · Oct 7, 2022
K211992 — Ortho MI System · Osteonic Co., Ltd. · Oct 15, 2021
K202790 — Syntec Orthodontic Mini Screw Extended System · Syntec Scientific Corporation · Sep 17, 2021
K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M · Ace Surgical Supply Co., Inc. · Aug 16, 2006
K113650 — ORTHOFIX SCREW · Bonafix Surgical and Dental Implants, LLC · Oct 3, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 6, 2019 Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 TAIWAN Re: K182929 Trade/Device Name: BIO-RAY A-1 Anchor Screw System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: October 7, 2019 Received: October 8, 2019 Dear Harrison Du: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K182929 Device Name BIO-RAY A-1 Anchor Screw System #### Indications for Use (Describe) The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only. 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(K) Summary Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Tel: +886-4-24636275 # 100 Fax: +886-4-24636276 Contact Name: Harrison Du Preparation date: Nov 06, 2019 Registration Number: 3007738812 Device Name: BIO-RAY A-1 Anchor Screw System Common Name: Orthodontic Screws Classification Name: Class II, Sec. 872.3640 Endosseous dental implant Product Code: OAT ### Predicate Device Information: | Primary device: | Syntec Orthodontic Mini Screws (K090476) | |-------------------|-----------------------------------------------------------| | Reference device: | Storm Mini Screw (K122069) | | | Absoanchor Microimplant (K060126) | | | Lin/Liou Orthodontic Mini Anchor System (Lomas) (K050257) | | | Tandry Locking Plate System (K171904) | ## Device Description: The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes as follows; {4}------------------------------------------------ | Model | A-1C | A-1P | A-1PL | A-1C IZC | | | | |--------------------------|------------------------------|---------------------------------|---------------------------------|---------------------------------|------|------|--------| | Material | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | | | | | Head type | Small Mushroom | Standard Mushroom | Standard Mushroom | Small Mushroom | | | | | Orthodontic Appliance | Coil Spring | Elastic Chain or Rubber Band | Elastic Chain or Rubber Band | Elastic Chain or Rubber Band | | | | | Diameter (mm) | 1.5 | 2.0 | 1.5 | 2.0 | 1.5 | 2.0 | 2.0 | | Length (mm) | 8-12 | 8-17 | 8-12 | 8-17 | 8-12 | 8-17 | 14, 17 | | Model | A-1P IZC | A-1H | A-1DH | A-1N | |--------------------------|---------------------------------|-------------------------------------------------|-------------------------------------------------|------------------------------| | Material | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | Stainless steel Ti-6Al-4V | | Head type | Standard Mushroom | Hook | Double Hook | None Head | | Orthodontic Appliance | Elastic Chain or Rubber Band | Coil Spring, Elastic Chain or Rubber Band | Coil Spring, Elastic Chain or Rubber Band | None | | Diameter (mm) | 1.5 2.0 | 1.5 2.0 | 1.5 2.0 | 1.5 2.0 | | Length (mm) | 14 14, 17 | 8-12 8-17 | 8-12 8-17 | 8-12 8-17 | ### Indication for use: The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended to be removed after orthodontic treatment has been completed. The screw is intended for single use only. ## Technological Characteristics: The BIO-RAY A-1 Anchor Screw System is similar to the predicate devices in features including indication for use, materials, dimensions, surface treatment, and sterilization as shown in Table 1 below. {5}------------------------------------------------ # Summary of Performance Data (Nonclinical and/or Clinical) # Clinical Performance Clinical studies were determined to be not required to support substantial equivalence. # Non-Clinical Performance - Bench Performance Tests The bench performance tests per ASTM F543 were conducted to determine substantial equivalence for the BIO-RAY A-1 Anchor Screw System. These tests included self-tapping, torsional, axial pullout, driving torque, and shear loading. Results indicate that the mechanical properties and performance of the proposed device are substantially equivalent to the predicate device. - Biocompatibility The proposed device is manufactured from stainless steel (ASTM F138) and titanium alloy ASTM F136). Cytotoxicity per ISO 10933-5, Sensitization and Intracutaneous Reactivity per ISO 10933-10, Acute Systemic Toxicity per ISO 10933-11, Material-Mediated Pyrogenicity per USP39/NF34(151), and Implantation per ISO 10993-6 were performed to mitigate the risks associated with materials used during manufacturing. - Sterilization Validation The sterilization validation was performed in according with the ISO 17665-1. The test results show that the acceptance criteria are met. - The BIO-RAY A-1 Anchor Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the BIO-RAY A-1 Anchor Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. # Summary of Substantial Equivalence: The BIO-RAY A-1 Anchor Screw System is substantially equivalent to the predicated devices. Results of non-clinical tests show substantial equivalence to the legally marketed predicate device, and indicate that the device will perform adequately for its intended use. {6}------------------------------------------------ | Table 1 | | | | | | | | | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|--| | | Proposed device | Primary predicate device | Reference predicate device | Reference predicate device | Reference predicate device | SE ? | | | | Device Name | Microware BIO-RAY A-1 Anchor Screw System | Syntec Orthodontic Mini Screws | ABSOANCHOR MICROIMPLANT | STORM MINI SCREW | Lin/Liou Orthodontic Mini Anchor System (Lomas) | NA | | | | 510K Number | K182929 | K090476 | K060126 | K122069 | K050257 | NA | | | | Trade Name | BIO-RAY A-1 | Syntec | DENTOS INC. | LANCER ORTHODONTICS, INC. | MONDEAL MEDICAL SYSTEMS GMBH | NA | | | | Indication for Use | The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended to be removed after orthodontic treatment has been completed. The screw is intended for single use only. | The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only. | The intended purpose of the AbsoAnchor Microimplant is to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. | The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only. | The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. | Yes | | | {7}------------------------------------------------ | Materials | SUS 316L: ASTM F138 (Refer to Appendix I- Cert No: 1210052459000020 01) | SUS 316L: ASTM F138 | Titanium Alloy: ASTM F136 | Titanium Alloy: ASTM F136 | Titanium Alloy: ASTM F136 | Yes | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------|-----| | | Titanium Alloy: ASTM F136 | Titanium Alloy: ASTM F136 | | | | | | | Screw thread diameter: 1.5 and 2.0mm | Screw thread diameter: 1.3, 1.4, 1.5 and 2.0mm | Screw thread diameter: 1.2-1.8mm | Screw thread diameter: 1.5 and 2.0mm | Screw thread diameter: 1.5, 2.0, and 2.3mm | | | Dimensions | Screw length: 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17mm | Screw length: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17mm | Screw length: 4-10mm & 12mm | Screw length: 8.0 and 10.0mm | Screw length: 7, 9, 11mm | Yes | | Screw Head Design | 1. Hook Type (A-1H) 2. Double Hook Type (A- 1DH) 3. None Head Type (A- 1N) 4. Standard Mushroom Type (A-1P) 5. Small Mushroom Type (A-1C) | 1. -- 2. -- 3. -- 4. Type I, II 5. Type I, II | 1. Hook Head Type (HH) 2. Bracket Head Type (BH) 3. No Head Type (NH) 4. Fixation Head Type (FH) 5. Small Head Type (SH) | 1. -- 2. Storm Mini-Screw 3. -- 4. -- 5.-- | 1. Hook Screw 2. QUATTRO Screw 3. — 4. Standard Screw 5. — | | | Surface | 1. Stainless steel screws: Electrolytic polishing 2. Titanium alloy screws: Anodizing | 1. Stainless steel screws: Electrolytic polishing 2. Titanium alloy screws: Anodizing | Titanium alloy screws: Anodizing | Titanium alloy screws: Anodizing | Titanium alloy screws: Anodizing | Yes | | Sterilization | Non-sterilize. Steam sterilization before use | Non-sterilize. Steam sterilization before use | Non-sterilize. Steam sterilization before use | Sterile via beta irradiation | Sterile | Yes | 5-6