REVOIS IMPLANT SYSTEM

K113042 · Riemser Arzneimittel AG · DZE · Mar 8, 2013 · Dental

Device Facts

• Record ID: K113042
• Device Name: REVOIS IMPLANT SYSTEM
• Applicant: Riemser Arzneimittel AG
• Product Code: DZE · Dental
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

Device Story

REVOIS® Implant System is a modular, screw-type dental implant system for jaw bone placement. Components include Grade V titanium implants, multifunctional precision abutments, and snap-on/transfer tools. Used by dentists/surgeons in clinical settings for dental restoration. Implants feature blasted/acid-etched surfaces and grooves to enhance primary stability and shear resistance. System supports one-stage (immediate loading) or two-stage (post-osseointegration) surgical protocols. Color-coded components facilitate diameter identification. Implants are supplied gamma-sterilized in double-sterile packaging for single use; reusable instruments require sterilization. Output is a stable foundation for prosthetic devices, benefiting patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical performance testing, including fatigue testing per ISO 14801 and bench testing using an animal model to evaluate implant stability.

Technological Characteristics

Grade V titanium construction (ASTM F067, ASTM F0136-2a, ASTM F2026). Screw-type implant with internal hex connection. Surface modified via aluminum oxide blasting and acid-etching. Gamma sterilization. Modular design with color-coded diameters (3.8, 4.3, 5.0 mm) and lengths (9, 11, 13, 15 mm).

Indications for Use

Indicated for patients with edentulous or partially edentulous jaw bone requiring support for prosthetic devices (single teeth, bridges, or dentures). Applicable for one-stage (immediate loading) or two-stage surgical procedures.

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

• REVOIS® Implant System (K063106)

Submission Summary (Full Text)

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KII 3042

REVOIS®

Special 510 (k) Summary

Section 4

RIEMSER C

Arzneimittel AG

## Special 510 (k) Summary:

# REVOIS® Implant System

MAR 8 2013

### SUBMISSION INFORMATION 1.

| Name and Address<br>of the Sponsor: | Riemser Arzneimittel AG<br>An der Wiek 7<br>17493 Greifswald-Insel Riems<br>Germany |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Date created | March 5, 2013 |
| Contact person: | Dr. Andreas Püttner<br>Head of Regulatory Affairs<br>Tel.: [phone]<br>Fax: [phone]<br>E - Mail: [e-mail] |
| Registered U. S. Agent: | James M. Clinton<br>5105 Fairoaks Rd.<br>Durham, NC 27712, USA<br>Phone: [phone], fax: [phone]<br>E - Mail: [e-mail] |

### DEVICE IDENTIFICATION 2.

| Proprietary Name: | REVOIS® Implant System |
|-----------------------------------|----------------------------|
| Common Name: | Dental implant system |
| Classification Name: | Endosseous Dental Implant |
| Classification: | Class II, Special Controls |
| Classification regulation Number: | 21CFR 872.3640 |
| Product Code: | DZE, Endosseous implant |

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KII3042

REVOIS® Section 4 Special 510 (k) Summary

#### 3. PREDICATE DEVICE

REVOIS® Implant System: K063106

### DESCRIPTION OF THE DEVICE 4.

The REVOLS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures.

The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool.

The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter.

The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026.

The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases.

The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only.

Tools and other re-usable instruments must be sterilized prior to use.

### 5. STATEMENT OF INTENDED USE

The REVOIS® Implant System is an implant system recommended for:

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# KI13042

| <i>REVOIS</i> ® | Section 4 |
|-------------------------|---------------------|
| Special 510 (k) Summary | Image: RIEMSER logo |

Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures.

The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

### STATEMENT OF TECHNOLOGICAL COMPARISON, BASIS FOR 6. SUBSTANTIAL EQUIVALENCE

The REVOIS® Implant System by Riemser is identical to the REVOIS® Implant System by cursan that was cleared by K063106. The ownership of the K063106 device was transferred from CURASAN AG to Riemser AG and FDA was notified by a letter to file. The Riemser device like the curasan device provides the same state-of-the art implant technology and options. The design and pre-assembled version of implant, abutment (which fits for all implants and implant diameters) and snap-on/transfer tool offer easy handling for the dentist/surgeon by reducing the number of components needed for successful placement of the implant, while ensuring precision and stability.

The stability of the implant body of the REVOIS® implant system thread was tested in non-clinical performance testing as fatigue testing according to ISO 14801 and Bench testing with Animal Model.

The essential similarity conclusion regarding the comparability of REVOIS® and REVOIS® (CURASAN, K063106)) are displayed in the following:

Both implant systems share similar indications for use. Both systems consist of screw form implants with internal hex connection consisting of different grades which is an inert, very durable material well known and used in implant surgery. They feature special threads and surfaces intended to support the primary stability of the implant and to ease the insertion, tissue adhesion and osseointegration of the implant into the bone. Both the curasan AG and Reimser AG systems provide implants in various diameters, lengths and color codes to accommodate different clinical situations as well as the matching tools, surgical instruments and accessories. The implants and pre-mounted components where applicable (REVOIS®, REVOIS® (CURASAN, K063106)), are supplied gamma sterilized in double sterile packaging. Differences between the Riemser REVOLS® and the curasan predicate device exist in the implant surface treatment; aluminium oxide blasted / acid etched (Riemser REVOIS®) and zirconium blasted / acidetched (REVOIS® (CURASAN, K063106)). Each system has a triple layer of sterility protection: PETG vial in glass vial, sealed in a blister at REVOIS®; the REVOIS® (CURASAN) comes with PET vial instead of PETG, while the blister and glass vial remain the same.

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# K113042

| <i>REVOIS</i> ® | Section 4 |
|-------------------------|---------------------|
| Special 510 (k) Summary | <br>Arzneimittel AG |

In summary, both systems are comparable in their main and most important characteristics. The differences between the systems represent minor updates as described and do not affect the device safety or effectiveness. The Riemser REVOIS® and the REVOIS® (CURASAN) implant systems are therefore substantially equivalent.

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Image /page/4/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 figure with three distinct lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper and lower portions of the circular logo.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2013

Riemser Arzneimittel AG C/O Mr. James M. Clinton Principal Consultant Quality & Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road DURHAM NC 27712

Re: K113042

Trade/Device Name: REVOIS® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 3, 2013 Received: February 13, 2013

### Dear Mr. Clinton:

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 - Mr. Clinton

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 devicerelated 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 electronic 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,

Image /page/5/Picture/6 description: The image shows the text "Kwame O. Ulmer for". The text "Kwame" is in a standard font, while "O. Ulmer" is stylized with a geometric, layered design. The word "for" is in a smaller, plain font to the right of "Ulmer".

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

K113042 510(k) Number (if known):

REVOIS® Implant System Device Name:

Indications for Use:

The REVOIS® Implant System is an implant system recommended for:

Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures.

The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

V Prescription Use (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)

Mary.S. Runner -
Susan Runner, DDS, BA
2013.03.07
09:15:53-05'00'

(Division Sign-Off) lon of Anesthesiology, General Hospital Infection Control. Dantal Devic

510(k) Number:

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