IMPLANT-ONE SYSTEM

K102822 · Custom Dental Implants, Inc. · DZE · Jan 10, 2011 · Dental

Device Facts

• Record ID: K102822
• Device Name: IMPLANT-ONE SYSTEM
• Applicant: Custom Dental Implants, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Device Story

Implant-One™ system consists of endosseous dental implants, cover screws, healing caps, and abutments; used by dental professionals for surgical placement in edentulous jaws. Implants are self-tapping, root-form, threaded titanium alloy (Ti-6Al-4V) or stainless steel; diameters 3.25-5.5mm; lengths 8-14mm. Features internal Morse style taper connection. Components provide prosthetic attachment base to restore patient chewing function. Immediate loading permitted contingent on primary stability and occlusal conditions. System components protect threads during healing. Clinical benefit includes restoration of masticatory function.

Clinical Evidence

No clinical data. Bench testing only. Dynamic mechanical testing performed per ISO 14801 on worst-case constructs demonstrated performance equivalent or superior to predicate devices.

Technological Characteristics

Materials: Titanium alloy (ASTM F1472) or stainless steel (ASTM A582). Design: Root-form, threaded, self-tapping endosseous implants. Connection: Internal Morse style taper with hex alignment. Surface: AlO2 blasted. Dimensions: 3.25-5.5mm diameter, 8-14mm length. Energy source: None (mechanical).

Indications for Use

Indicated for patients with partially or completely edentulous upper or lower jaws requiring prosthetic attachment to restore chewing function. Suitable for immediate loading if primary stability and appropriate occlusal loading are achieved.

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

• Biomet 3i dental implants and abutments (K063341/K072642)
• Zimmer Screw Vent and Contour Abutment (K061410/K061847)
• FRIADENT Implant Systems (K073075)

Submission Summary (Full Text)

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K102822

# Custom Dental Implants

Norwalk, WI 54648

JAN 1 0 2011

-

Image /page/0/Picture/4 description: The image shows the logo for Implant-One Dental Implants. The logo features a stylized image of a tooth on the left side. The text "Implant-One" is written in a bold, sans-serif font, with the words "Dental Implants" written in a smaller font below.

# 510(k) Summary

| Date: | 20 December 2010 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Custom Dental Implants Inc.<br>18975 Incline Road<br>Norwalk, WI 54648<br>Phone [phone] |
| Contact Person: | Thomas Arendt, Vice President |
| Proposed Trade<br>Name: | Implant-One™ Dental Implants |
| Device Classification | Class II |
| Classification Name: | Endosseous dental implant & Endosseous dental implant abutment |
| Regulation: | 872.3640 & 872.3630 |
| Device Product<br>Codes: | DZE & NHA |
| Device Description: | The Implant-One™ Dental Implants include endosseous dental<br>implants, cover screws, healing caps, dental implant abutments and<br>abutment screws in a variety of sizes to accommodate differing<br>patient anatomy. Endosseous implants are self-tapping, root-form<br>and threaded. They range from 3.25mm to 5.5mm in diameter with<br>lengths ranging from 8mm to 14mm and have an internal, threaded<br>abutment connection having a Morse style taper. Cover screws and<br>healing caps provide protection to the threads of the abutment<br>connection during endosseous and gingival healing. Cover screws<br>are pre-packaged with each implant. Healing caps are provided as<br>an alternative to the cover screw and are packaged separately.<br>Abutment options include Standard and Restorative in various<br>heights. These are fastened to the implant using an abutment screw. |
| Intended Use: | The Implant-One™ system is indicated for surgical placement in<br>partially or completely edentulous upper or lower jaws to provide a<br>means for prosthetic attachment to restore a patient's chewing<br>function. The Implant-One™ system is indicated for immediate<br>loading only when primary stability is achieved and with the<br>appropriate occlusal loading. |
| Materials: | The Implant-One™ components are manufactured from titanium<br>alloy (Ti-6Al-4V) as described by ASTM F1472 or stainless steel<br>according to ASTM A582. |
| Predicate Devices: | Biomet 3i dental implants and abutments (K063341/K072642)<br>Zimmer Screw Vent and Contour Abutment (K061410/K061847)<br>FRIADENT Implant Systems (K073075) |

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The fundamental scientific technology of the Implant-One™ system Technological is the same as previously cleared devices as shown below. Characteristics:

| System: | Implant-One | Biomet 3i | Zimmer | Ankylos | |
|-----------------------------|----------------------------------------------------------|---------------------------------------|-------------------------------------------------|---------------------------------------------------------------------|--|
| Material of<br>manufacture: | Titanium and/or titanium alloy | | | | |
| Design: | | | | | |
| Endosseous implant | Root-form,<br>Tapered | Root-form,<br>Straight and<br>tapered | Root-form,<br>Straight and<br>tapered | Root-form,<br>Straight | |
| Method of<br>stabilization | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | |
| Range of Diameters | 3.25 - 5.5mm | 3.25 - 6mm | 3.3 - 6mm | 3.5 - 7.0mm | |
| Range of Lengths | 8 - 14mm | 8.5 - 15mm | 8 - 16mm | 8 - 17mm | |
| Modified surface | Yes, AlO2<br>blasted | Yes, acid etched | Yes,<br>microtextured or<br>HA coated | Yes, grit blasted<br>and etched | |
| Connection to<br>abutment | Hex alignment,<br>6° included taper,<br>screw attachment | Hex alignment,<br>screw attachment | Hex alignment,<br>1° taper, screw<br>attachment | Keyed<br>alignment,<br>friction-lock<br>taper, thread<br>attachment | |
| Abutments | Standard, Ball,<br>Gold coping | Standard, Ball | Standard, Ball,<br>Gold coping | Standard, Ball,<br>Gold coping | |

Non-clinical dynamic testing of the worst case Implant-One™ system Performance Data: construct was performed according to ISO 14801. The mechanical test results demonstrated that the Implant-One™ system performs as well as or better than the predicate devices. No clinical data was used in support of this submission.

The Implant-One™ system is substantially equivalent to the Conclusion: predicate devices referenced above is therefore safe and effective for its intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002

Custom Dental Implants, Incorporated C/O Ms. Karen E. Warden President BackRoads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026

JAN 1 0 201

Re: K102822

Trade/Device Name: Implant-One" System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant & Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE & NHA Dated: December 21, 2010 Received: December 23, 2010

Dear Ms. Warden:

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.

:

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Page 2- Ms. Warden

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 clectronic 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

4102822 510(k) Number:

### Device Name: Implant-One™ System

Indications for Use:

The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-Counter Use_

(21 CFR 801 Subpart D)

(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)

Simon Rogers

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

510(k) Number: K102833