HDC SPIDER SCREW

K052471 · Hdc S.R.L. · DZE · Dec 23, 2005 · Dental

Device Facts

• Record ID: K052471
• Device Name: HDC SPIDER SCREW
• Applicant: Hdc S.R.L.
• Product Code: DZE · Dental
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the tecth. The device is used temporarily and shall be removed after orthodontic treatment.

Device Story

HDC Spider Screw is a threaded titanium bone screw; functions as temporary fixed anchorage for orthodontic appliances. Inserted into upper or lower jaws by clinician. Available in self-tapping (ASTM F67) and self-drilling/self-tapping (ASTM F136) configurations. Tip diameters: 1.5 mm and 2.0 mm. Device provides stable point for orthodontic force application; facilitates tooth movement. Removed after treatment completion. Non-sterile; requires sterilization before use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium bone screws. Self-tapping version: ASTM F67. Self-drilling/self-tapping version: ASTM F136. Diameters: 1.5 mm and 2.0 mm. Non-sterile; requires sterilization.

Indications for Use

Indicated for patients requiring orthodontic treatment; serves as a temporary fixed anchorage point for orthodontic appliances to facilitate 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

• Tomas-pin (K042965)
• Dual Top Anchor System (K033767)
• AARHUS Anchorage System (K041527)
• Replace Scalloped Margin Implant System (K021584)

Submission Summary (Full Text)

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Applicant:

DEC 2 3 2005

KOS2471

## 510(k) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS

HDC s.r.l Via dell'Industria, 19 36030 – SARCEDO (Vicenza) - Italy Tel: [phone] Fax: [phone]

> Contact Person: Guido Bonapace I.SE.NET. Via Emilia, 418, 40068 - San Lazzaro di Savena (Bologna) - Italy Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: September 2, 2005

#### Device Name

| Proprietary Name : | HDC Spider Screw |
|------------------------|---------------------------------------------|
| Common/Usual Name: | Bone Screw |
| Classification Names: | Endosseous dental implant |
| Device Classification: | Class II, 21 CFR 872.3640, Product Code DZI |

#### Predicate Devices:

| 510 K Number | Device Trade Name | Manufacturer |
|--------------|-----------------------------------------|---------------|
| K042965 | Tomas-pin | Dentaurum |
| K033767 | Dual Top Anchor System | Jeil Medical |
| K041527 | AARHUS Anchorage System | Medicon |
| K021584 | Replace Scalloped Margin Implant System | Nobel Biocare |

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## Device Description:

The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.

### Basis of Substantial Equivalence:

HDC Spider Screws are similiar to predicate devices in intended use, material, design, and function. The intended use is identical to K033767 and K041527. The design is substantially equivalent to K033767 and K041527.

### Intended Use:

The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the tecth. The device is used temporarily and shall be removed after orthodontic treatment.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three trailing lines, representing the department's mission to protect the health of all Americans and provide essential human services.

DEC 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HDC S.R.L. C/O Ms. Millie Lynn Bentley Consultant Alta Consulting 6512 Bannockburn Drive Bethesda, Maryland 20817

Re: K052471

Trade/Device Name: HDC, Spider Screw Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 23, 2005 Received: November 25, 2005

Dear Ms. Bentley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally by the device is substantially equivalent (for the referenced above and have determined ue) to legally marketed predicate devices marketed in indications for use stated in the enclosars, to engines date of the Medical Device merstate connifieree prior to way 20, 1970, career with the provisions of Amenditents, of to devices that nave obsit (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosment . For (Pres) ----------------------------------------------------------------------------------------------------------------------------approval application (1 Mr.). - 1 ou ne), controls provisions of the Act include confors provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for nibitions 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 (PMA), it may be subject to such adam first oral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Peaces oncerning your device in the Federal Register.

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Page 2 - Ms. Bentley

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualles of a bassaures complies with other requirements mean that FDA nas made a decemination until your and ministered by other Federal agencies. of the Act of ally receitar statutes and regarants, including, but not limited to: registration You must comply with an the Hotel Stog (21 CFR Part 801); good manufacturing practice and listing (21 CrK Part 607), labeling (21 CFR Pat 820), and if 51 CFR Pat 820), and if requirements as set forum in the quality bysteins (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 you to begin malier and your substantial equivalence of your device to a premiarket notification. The PDF mailing of 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 advice for your de roo at [phone]. Also, please note the regulation prease contact the Other or Somphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general mironmational and Consumer Assistance at its toll-free Division of Bintas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite y. Michael Ows

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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# Indications for Use

510(k) Number : Koszy71

Device Name: HDC, Spider Screw

Indications for Use:

The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Ki Muly for MSR