SCREWINDIRECT DENTAL IMPLANTS

K080633 · Implant Direct, LLC · DZE · Jul 15, 2008 · Dental

Device Facts

• Record ID: K080633
• Device Name: SCREWINDIRECT DENTAL IMPLANTS
• Applicant: Implant Direct, LLC
• Product Code: DZE · Dental
• Decision Date: Jul 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ScrewIndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

Device Story

ScrewIndirect Narrow Dental Implants are tapered, screw-type endosseous dental implants; manufactured from medical grade titanium alloy with soluble blast media (SBM) coating. Device features standard 'V' thread configuration and 2mm mini-threads at the coronal aspect. Designed for single-stage surgical placement in mandibles or maxillae with limited buccal-lingual bone availability. Operated by dental surgeons in clinical settings. Implants serve as anchors for prosthetic attachments (copings) to support dentures or bridgework. Immediate loading is permitted for splinted multiple tooth restorations when clinical stability and occlusal criteria are satisfied. The 3.0mm diameter variant expands the existing product line to accommodate patients with reduced bone volume.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Medical grade titanium alloy. Surface: Soluble blast media (SBM) coating. Design: Tapered screw-type endosseous implant with 'V' thread configuration and 2mm mini-threads. Diameter: 3.0mm. Sterilization: Not specified.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implants in the mandible or maxilla to support complete or partial dentures or fixed/removable bridgework. Supports immediate loading for splinted multiple tooth restorations if initial stability and occlusal load requirements are met.

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

• Implant Direct's Spectra-System (K061319)

Submission Summary (Full Text)

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K080633

Image /page/0/Picture/1 description: The image shows the logo for Implant Direct LLC. The logo features a large letter "D" with a hexagon in the upper left corner. To the right of the "D" is the word "Implant" stacked on top of the words "Direct LLC". Below the logo is the website address www.implantdirect.com.

JUL 1 5 2008 ScrewIndirect Narrow Dental Implants Traditional 510(K) Submission

## 510(K) Summary (21CFR 807.92(a))

- 1. Submitter's Information Company Name: Implant Direct LLC Address: 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Telephone Number: 818-444-3300 Fax Number: 818-444-3400 Registration Number: 3001617766 Contact Person: Tom Gottenbos Date Summary Prepared: June 27, 2008 Classification Name: Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant
- 2. Device Trade Name: ScrewIndirect Dental Implants
- 3. Predicate Device(s): Implant Direct's Spectra-System (K061319)

#### 4. Device Description:

The ScrewIndirect Narrow Dental Implants consist of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are coated with the same soluble blast media (SBM). The 3.0mmD implants are in addition to previously approved implants in this system, and are the sole subject of this submission.

#### 5. Intended Use:

ScrewIndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

#### 6. Device Comparison:

This submission comprised of implants whose physical dimensions, material composition, and manufacture were approved in a previous 510K (K061319) but are now being offered an additional diameter. The ScrewIndirect implants approved under K061319 were offered in the 3.7mm, 4.7mm, and 5.7mm body diameter. This submission adds a 3.0mm body diameter to this product family. The smaller diameter reduces the requirements made for the buccal-lingual bone dimension, permitting placement in areas with less bone availability.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

IJUL 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Gottenbos Vice President of I'l' Regulatory Affairs Implant Direct LLC 27030 Malibu Hills Road Calabasas Hills, California 91301

Re: K080633

Trade/Device Name: ScrewIndirect Narrow Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 27, 2008 Received: July 1, 2008

Dear Mr. Gottenbos:

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. Gottenbos

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.

Susan Runne

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 (if known): K080633

Device Name: ScrewIndirect Narrow Dental Implants

Indications for Use:

ScrewIndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AS. Betz DDS for Dr. Susan Brunner

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

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