(513 days)
Not Found
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is an implant system used for supporting prosthetic devices for dental restoration, not for treating a disease or condition.
No
The device description indicates that the REVOIS® Implant System is an implant system used for surgical placement in the jaw bone to support prosthetic devices. It is a physical implant, not a tool used to diagnose conditions or diseases.
No
The device description clearly states it is a physical implant system made of titanium, including implants, abutments, tools, and instruments. It is not solely software.
Based on the provided information, the REVOIS® Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for surgical placement in the jaw bone to support prosthetic devices. This is a surgical procedure involving implantation into the body, not a test performed on samples taken from the body.
- Device Description: The device is a physical implant made of titanium, along with associated tools and components for surgical placement and prosthetic attachment. It does not involve reagents, calibrators, or other components typically associated with in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly a surgical implant system used for dental restoration.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous or partially edentulous jaw bone (upper or lower jaw bone)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist/surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
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
of the Sponsor: | Riemser Arzneimittel AG
An der Wiek 7
17493 Greifswald-Insel Riems
Germany |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Date created | March 5, 2013 |
| Contact person: | Dr. Andreas Püttner
Head of Regulatory Affairs
Tel.: +49-3835-1760
Fax: +49-3835-176778
E - Mail: dr.puettner@riemser.de |
| Registered U. S. Agent: | James M. Clinton
5105 Fairoaks Rd.
Durham, NC 27712, USA
Phone: 919-247-0479, fax: 919-287-2551
E - Mail: clintonjm@earthlink.net |
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 |
1
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:
2
KI13042
| REVOIS ® | 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.
3
K113042
| REVOIS ® | Section 4 |
|---|---|
| Special 510 (k) Summary | |
| 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.
4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
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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