SIMPACT IMPLANT SYSTEM

K081226 · Simpact, LLC · DZE · Sep 12, 2008 · Dental

Device Facts

• Record ID: K081226
• Device Name: SIMPACT IMPLANT SYSTEM
• Applicant: Simpact, LLC
• Product Code: DZE · Dental
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket. The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

Device Story

SIMPACT Endosseous Dental Implant is a threaded, tapered internal connection implant used in dental surgery. Designed for placement in partially or fully edentulous mandibles and maxillae; supports single or multiple-unit restorations, including cement-retained fixed bridgework. Supports immediate placement protocols (at time of tooth extraction) and immediate provisional loading (interim prosthesis placement at same visit) provided primary stability and proper occlusion exist. Used by dental clinicians in clinical settings. Device provides structural foundation for prosthetic teeth; benefits patients by enabling immediate restoration of function and aesthetics following tooth extraction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Threaded/tapered internal connection endosseous dental implant. Materials and design are similar to predicate devices. No specific ASTM standards or software/algorithm components described.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations, including cement-retained fixed bridgework. Suitable for immediate placement into extraction sockets and immediate provisional loading when primary stability and proper occlusion 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

• Lifecore Biomedical (K051614)
• Friadent (K041509)
• Ankylos (K012681)
• CAMLOG (K00099)

Submission Summary (Full Text)

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K081226

## SEP 1 2 2008

# 510(k) Summary of Safety and Effectiveness:

### SIMPACT Implant System

| Submitter: | SIMPACT LLC<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Alan Lombardo<br>President<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | September 2, 2008 |
| Trade Name | SIMPACT Endosseous Dental Implant |
| Classification Name<br>and Number | Endosseous dental implant and abutment<br>21 CFR 872.3630<br>21 CFR 872.3640 |
| Product Code | DZE, NHA |
| Predicate Devices | Lifecore Biomedical K051614<br>Friadent K041509<br>Ankylos K012681<br>CAMLOG K00099 |
| Device Description | The SIMPACT Endosseous Dental Implant System. |
| Intended Use | Simpact Dental Implant System is intended for use in partially<br>or fully edentulous mandibles and maxillae, in support of single<br>or multiple-unit restorations including; cement retained terminal<br>or intermediate abutment support for fixed bridgework. |
| | The Simpact implant is a threaded/tapered internal connection |
| | implant. The Simpact implant is intended for immediate |
| | placement, where immediate implant placement is defined by |
| | the International Congress of Oral Implantologists (ICOI) as the |
| | placement of an implant at the time of tooth extraction, into the |
| | extraction socket. |
| | |
| | The Simpact implant is intended for immediate |
| | provisional loading when primary stability and proper occlusion |
| | are present. Immediate Provisionalization is defined by the |
| | International Congress of Oral Implantologists (ICOI) as a |
| | clinical protocol for the placement of an interim prosthesis |
| | with occlusal contact with the opposing dentition, at the same |
| | clinical visit of implant placement. The Simpact implant can be |
| | restored with a temporary prosthesis in single tooth and multiple |
| | tooth applications. |
| | |
| Statement of | The SIMPACT implant system and its predicate devices have |
| Technological | the same indications for use have a similar design and are made |
| Comparison | of the similar materials. |
| Conclusion | The SIMPACT implant system is substantially equivalent to its |
| | predicate devices. This conclusion is based upon the fact that |
| | this device is substantially equivalent in terms of indications for |
| | use, materials, design and principles of operation. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

Mr. Alan Lombardo Simpact, LLC 300 Interpace Parkway Building C 3rd Floor Parsippany, New Jerscy 07054

Rc: K081226

Trade/Device Name: SIMPACT Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 2, 2008 Received: September 3, 2008

Dear Mr. Lombardo:

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. Lombardo

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Khamails Ludi-r for u

Chiu S. Lin, Ph. D Division 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 K081226

SIMPACT Endosseous Dental Implant

Indications for Use:

Device Name:

Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae; in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.

The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.

The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runpe

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

510(k) Number: LCDS12076

Revised September 2, 2008