HDC STERILE SPIDER SCREW

K071851 · Hdc S.R.L. · DZE · Oct 18, 2007 · Dental

Device Facts

• Record ID: K071851
• Device Name: HDC STERILE SPIDER SCREW
• Applicant: Hdc S.R.L.
• Product Code: DZE · Dental
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HDC Sterile 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. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.

Device Story

HDC Sterile Spider Screw is a titanium bone screw used as temporary orthodontic anchorage. Device inserted into upper or lower jaws by clinician; serves as attachment point for orthodontic appliances to facilitate tooth movement. Available in 'Self Tapping' and 'Self Drilling and Self Tapping' configurations; tip diameters 1.3mm, 1.5mm, 2.0mm. Provided sterile for single use; removed upon completion of orthodontic treatment. Benefits include stable anchorage for complex tooth movements.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Titanium bone screw; materials conform to ASTM F67 and ASTM F136. Available in self-tapping or self-drilling/self-tapping configurations. Tip diameters: 1.3mm, 1.5mm, 2.0mm. Sterile, single-use device.

Indications for Use

Indicated for patients requiring orthodontic tooth movement; serves as temporary fixed anchorage point for orthodontic appliances in upper or lower jaws. Contraindicated for permanent implantation; must be removed post-treatment.

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

• Spider Screw (K052471)
• Tomas-pin (K062733)
• Dual Top Anchor System (K033767)

Submission Summary (Full Text)

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# Kolle

## HDC Health Development Company

# 007 1 8 2007

### 510(k) SUMMARY

### SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | HDC s.r.l<br>Via dell'Industria, 19<br>36060 - SARCEDO (Vicenza) - Italy<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marco Benvegnù |
| Alternate Contact Person: | Guido Bonapace (consultant)<br>ISENET<br>Via Calindri, 50<br>40068 - San Lazzaro di Savena (Bologna) - Italy<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date: | October 17, 2007 |
| Device Name<br>Proprietary Name : | HDC Sterile Spider Screw |
| Common/Usual Name: | Bone Screw |
| Classification Names: | Endosseous dental implant |
| Device Classification: | Class II, 21 CFR 872.3640, Product Code DZE |

| 510 K<br>Number | Device Trade Name | Manufacturer |
|-----------------|------------------------|--------------|
| K052471 | Spider Screw | HDC |
| K062733 | Tomas-pin | Dentaurum |
| K033767 | Dual Top Anchor System | Jeil Medical |

Appendix H - Page 1 di 2

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## HDC Health Development Company

#### Device Description:

The HDC Sterile Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws. designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Spider Screw is provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screw is manufactured from ASTM F67 and ASTM F136. Self Drilling and Self Tapping Spider Screw is manufactured from ASTM F136. HDC Sterile Spider Screw is provided in three tip size diameters: 1.3 mm, 1.5 mm and 2.0 mm.

#### 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 K052471 and K062733. The design is substantially equivalent to K052471 and K062733. The anchorage system of the PIN model is substantially equivalent to the K033767.

#### Intended Use:

The HDC Sterile 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. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three bars forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

HDC s.r.l C/O Mr. Guido Bonapace Consultant ISENET Via Calindri, 50 San Lazzaro di Savena, Bologna ITALY 40068

Re: K071851

Trade/Device Name: HDC, Sterile Spider Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: September 27, 2007 Received: October 9, 2007

Dear Mr. Bonapace:

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. Bonapace

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snyde Y. Michon Oms.

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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HDC Health Development Company

# Indications for Use

10 1831 510(k) Number :

Device Name: HDC, Sterile Spider Screw

Indications for Use:

The HDC Sterile 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. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.

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 (ODE)

Sues Roare

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

510(k) Number. k07185.