STORM MINI SCREW

K122069 · Lancer Orthodontics, Inc. · OAT · Apr 11, 2013 · Dental

Device Facts

• Record ID: K122069
• Device Name: STORM MINI SCREW
• Applicant: Lancer Orthodontics, Inc.
• Product Code: OAT · Dental
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Storm Mini Screw is a self-drilling, self-tapping endosseous dental implant; constructed of grade 5 titanium (Ti6Al4V); used by dental/orthodontic specialists in clinical settings. Device provides fixed anchorage point for orthodontic appliances (wires, springs, elastic ligatures) to facilitate tooth movement. Implanted into maxillary/mandibular alveolar ridges or interradicular areas; removed after treatment completion. Single-use; provided sterile via beta irradiation. Mechanical strength verified via static load testing at 90 degrees to axis. Benefits include temporary, stable anchorage for complex orthodontic corrections.

Clinical Evidence

Bench testing only. Static load resistance tests performed at 90 degrees to the screw axis confirmed mechanical strength equivalent to predicates. Sterilization validation reached VD Max25 dosage; accelerated aging confirmed 5-year sterile shelf life.

Technological Characteristics

Grade 5 titanium (ASTM F136-95); self-drilling and self-tapping; conical thread with asymmetrical profile; 1.5mm and 2.0mm body diameters; 8mm and 10mm lengths; variable neck lengths (1.5mm and 3mm) for transmucosal adaptation; sterile via beta irradiation; biocompatible/anodized.

Indications for Use

Indicated for patients requiring orthodontic treatment to provide fixed anchorage for appliance attachment and tooth movement. Contraindications not specified.

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

• HDC Spider Screw (K071851)
• Orthodontic TAADS (K063149)

Submission Summary (Full Text)

{0}------------------------------------------------

R122069

Premarket Notification 510(k) - Storm Mini Screw - Lancer Orthodo

APR 1 1 2013

Image /page/0/Picture/3 description: The image shows the logo for Lancer Orthodontics since 1967. The logo features the word "Lancer" in a bold, stylized font, with the word "Orthodontics" written in a smaller font underneath. There is a graphic of the earth below the text. The logo has a swoosh design element that goes through the word "Lancer".

## 510(k) Summary

Submitter's name: Address:

Name of contact person:

Date the summary was prepared: Name of the device: Trade or proprietary name: Common or usual name: Regulation description Class Product Code: 21 CFR Regulation Number:

Lancer Orthodontics 2330 Cousteau Court Vista, California 92081 Telephone: [phone] Facsimile: [phone]

Larry Walker Regulatory & Quality Systems Manager Lancer Orthodontics 2330 Cousteau Court Vista, California 92081 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

April 4, 2013 Mini screw Storm Mini Screw Orthodontic mini screw Endosseous dental implant. II (two) OAT 872.3640

The legally marketed device to which we are claiming equivalence as per CFR 21 872:3640:

HDC Spider Screw - Temporary Anchorage Device System, 510(k) reference number K071851

T.O.A.D.S., LLC, Orthodontic TAADS (Temporary Anatomical Anchor Device System), 501(k) reference number K063149

The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed

Description of the device:

5-2

{1}------------------------------------------------

placement of orthodontic appliances such as wires.

devices.

springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed.

to be immediately used as an anchorage for orthodontic

The Storm mini-screw head is designed to facilitate

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.

Description of Performance Tests:

The Storm Mini Screw has been tested to verify performance characteristics under a static load resistance in order to simulate the geometric conditions to which the device would be subjected to in clinical practice. Static load tests were performed by applying a load at 90° with respect to the axis of the Storm Mini Screw. The test results concluded that the Storm Micro Screw provides adequate mechanical strength for its intended use in an orthodontic application and has equivalent performance to the predicate devices. Tests for sterilization validation indicated that treatment method reached the established VD Max25 dosage. Test certifications performed after sterilization and accelerated ageing confirmed a 5 year sterile shelf life.

## Summary of Substantial Equivalence:

Lancer Orthodontics has identified two predicate devices: the Sterile Spider Screw from HDC s.r.l. (ref. K071851) and Orthodontics TAADS from T.O.A.D.S LLC (ref. K063149). The Storm Mini Screw was compared to the two predicate devices in the following areas and was found to have similar or better technological characteristics and was determined to be substantially equivalent

| | Storm Mini Screw | Predicate,<br>HDC Spider Screw | Predicate,<br>Orthodontic TAADS |
|-----------------|--------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Intended Use | The Storm Mini Screw is a<br>threaded titanium dental | The HDC sterile Spider<br>Screw is a threaded titanium | The Orthodontic TAADS<br>Screws are intended to |
| | | | |
| | implant screw intended to<br>provide a fixed anchorage | dental implant screw,<br>intended to serve as a fixed | provide a fixed anchorage |
| | point for the attachment of | anchorage point for | point for the attachment of |
| | orthodontic appliances and | attachment of orthodontic | orthodontic appliance to |
| | facilitate the orthodontic | appliances to facilitate the | facilitate the orthodontic |
| | movement of teeth. It is used | orthodontic movement of the | movement of teeth. They |
| | temporarily and must be | teeth. It is used temporarily | are intended for temporary |
| | removed after orthodontic | and must be removed after | use and should be removed |
| | treatment has been | the orthodontic treatment has | after orthodontic treatment<br>has been completed. The |
| | completed. The Storm Mini | been completed. It is | screws are intended for |
| | Screw is provided sterile and | provided sterile and is | single use only. |
| | is intended for single use | intended for single use only. | |
| | only. | | |
| Target | People having orthodontia | People having orthodontia | People having orthodontia |
| Population | work | work. | work |
| | | | |
| Technological | Self-drilling and Self-tapping | Self-drilling and Self-tapping | Not self-drilling (requires |
| Characteristics | | | pre-drilling), Self-tapping |
| | | | |
| | Orthodontic head for | Orthodontic head for | Orthodontic head for |
| | appliance placement | appliance placement | appliance placement |
| | Two different diameter | Two different diameter | Two different diameter |
| | bodies: 1.5 mm and 2.0 mm | bodies: 1.5 mm and 1.9 mm | bodies: 1.5 mm and 2.5 mm |
| | | | |
| | Conical thread with | Conical thread with | Conical.thread with |
| | asymmetrical profile | asymmetrical profile | asymmetrical profile |
| | | | |
| | Single use | Single use | Single use |
| | Length 8 mm & 10 mm | Length range: 5 mm - 11 mm | Length (information not |
| | | | publicly available) |
| | The neck length of | The neck length of | Neck Length (information |
| | transmucosal portion is | transmucosal portion is | not publicly available) |
| | variable to provide | variable to provide adaptation | |
| | adaptation for different | for different intraoral mucosa | |
| | intraoral mucosa thickness: | thickness: neck length 1 and | |
| | neck lengths: 1.5 and 3 mm | 2 mm | |
| Materials | Grade 5 Titanium | Grade 5 Titanium | Grade 5 Titanium |
| | ASTM F136-95 Standard | ASTM F136-95 Standard | ASTM F136-95 Standard |
| | Specification for Wrought | Specification for Wrought | Specification for Wrought |
| | Titanium-6 Aluminum-4 | Titanium-6 Aluminum-4 | Titanium-6 Aluminum-4 |
| | Vanadium ELI (Extra Low | Vanadium ELI (Extra Low | Vanadium ELI (Extra Low |
| | Interstitial) Alloy for Surgical | Interstitial) Alloy for Surgical | Interstitial) Alloy for Surgical |
| | Implant Applications | Implant Applications | Implant Applications |
| | Storm Mini Screw | Predicate. | Predicate, |
| | | HDC Spider Screw | Orthodontic TAADS |
| Where Used | Dental and orthodontic | Dental and orthodontic | Dental and orthodontic |
| | specialists offices | specialists offices | specialists offices |

Intended Use:

{2}------------------------------------------------

Premarket Notification 510(k) – Storm Mini Screw - Lancer Orthodonlics

{3}------------------------------------------------

Premarket Notification 510(k) – Storm Mini Screw - Lancer Orthodontics

| Sterility | Sterile via beta irradiation | Sterile via gamma radiation | Sterile and non-sterile,<br>(Information on method of<br>sterilization is not publicly<br>available) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 5 year Sterile Shelf Life | Shelf Life of Sterility is not<br>publicly available information | Shelf Life of Sterility is not<br>publicly available<br>information |
| Biocompatibility | Made of biocompatible,<br>medical grade anodized<br>titanium<br>ISO 10993 compliant | Made of biocompatible,<br>medical grade titanium | Made of biocompatible,<br>medical grade anodized<br>titanium |
| Anatomical Sites | Maxillary edentulous<br>alveolar ridges<br>Maxillary Buccal/lingual<br>interradicular areas<br>Mandibular edentulous<br>alveolar ridges<br>Mandibular Buccal/lingual<br>interradicular areas<br>Mandibular Buccal shelf at<br>the oblique area<br>Mandibular retromolar area | Maxillary edentulous alveolar<br>ridges<br>Maxillary Buccal/lingual<br>interradicular areas<br>Mandibular edentulous<br>alveolar ridges<br>Mandibular Buccal/lingual<br>interradicular areas<br>Mandibular Buccal shelf at<br>the oblique area<br>Mandibular retromolar area | Unknown from published<br>documentation |
| Mechanical<br>Safety | ASTM F136-95 Standard<br>Specification for Wrought<br>Titanium-6 Aluminum-4<br>Vanadium ELI (Extra Low<br>Interstitial) Alloy for Surgical<br>Implant Applications | ASTM F136-95 Standard<br>Specification for Wrought<br>Titanium-6 Aluminum-4<br>Vanadium ELI (Extra Low<br>Interstitial) Alloy for Surgical<br>Implant Applications | ASTM F136-95 Standard<br>Specification for Wrought<br>Titanium-6 Aluminum-4<br>Vanadium ELI (Extra Low<br>Interstitial) Alloy for Surgical<br>Implant Applications |

.

:

:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is horizontally oriented and appears to be the heading of a document or publication. The words are all capitalized and evenly spaced.

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure.

## · April 11, 2013

Mr. Larry Walker Regulatory & Quality Systems Manager Lancer Orthodontics 2330 Cousteau Court VISTA CA 92081

Re: K122069

Trade/Device Name: Storm Mini Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: March 8, 2013 Received: March 11. 2013

Dear Mr. Walker:

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.

Public Health Service

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

{5}------------------------------------------------

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Image /page/5/Picture/8 description: The image shows the words "Kwame O. Ulmer-S" in a bold, sans-serif font. The letters are arranged in two rows, with "Kwame O." on the top row and "Ulmer-S" on the bottom row. Behind the text is a stylized image of a building or structure, possibly an architectural design. The image is black and white and appears to be a scan or photocopy.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known):_ K 122069

Device Name: _ Storm Mini Screw

Indications For Use:

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.

Prescription Use X

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S 2013.04.09 13:32:42 -04'00'

(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number: K122064

4-2