REVOIS PRO 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 (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).

Device Description

The REVOIS® PRO 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® PRO Implant System is composed of a titanium screw type cylindrical implant. It is a screw form implant with cylindrical thread and a progressive thread near the apex. The double thread of the implant body is contiguous with the triple thread (fine thread) at the implant neck. Together with the conical implant body of the REVOIS®: PRO implant, the progressive thread makes sure that the implant is well anchored in the host bone of the alveolar crest. The incremental pitch of the thread upwards evenly distributes the forces so that implants heal well and can be loaded immediately.

The implant system is delivered in a sterile insert blister and comprises an implant, an impression abutment, an impression screw and a cover screw (sterile packed as a set in a blister packaging). The impression screw serves as a connector between impression abutment and implant so that the pre-assembled parts fit tightly into the inlay for sterility reasons. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). For ease of identification the implants are color coded according to diameter.

The dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently:

Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5
Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5
Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy
Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5
Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5
Locator* abutment, made of Titanium Grade 5
Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5
Locator® impression coping, made of the Aluminium Alloy 6061
Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium Grade 5

The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106.

The main components of the implant system are made of Grade V Titanium (implant, abutment). The materials comply with the ASTM standards ASTM F067 (implant) and ASTM F0136-2a (abutment). The implant surface is blasted with luminium oxide particles (Corundum) and then acid-etched for micro-roughness.

The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

AI/ML Overview

The acceptance criteria and study proving the device meets them are not explicitly detailed in the provided text in the format typically expected for AI/medical device performance evaluation reports (e.g., sensitivity, specificity, accuracy against a gold standard).

This document is a 510(k) summary for a dental implant system (REVOIS® PRO Implant System), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on presenting novel performance study results for a new AI algorithm.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in:

Category	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the summary)
Intended Use	Must be for surgical placement in edentulous or partly edentulous jaw bone to support prosthetic devices (single artificial teeth, fixed/removable bridges, dentures).	The REVOIS® PRO Implant System is recommended for surgical placement in the edentulous or partly 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. Can be applied in one-stage (immediate loading with good primary stability) or two-stage (after osseointegration) surgical procedures. This matches the predicate device.
Technological Characteristics (Design, Materials, Performance)	Must be essentially similar in design, materials, and performance aspects, or any differences must not affect safety or effectiveness.	Device Design: Titanium screw-type cylindrical implant with cylindrical and progressive threads. Double thread of implant body contiguous with triple (fine) thread at implant neck. Conical implant body. Available in various diameters (3.8, 4.3, 5.0 mm) and lengths (9, 11, 13, 15 mm). Color-coded. Materials: Grade V Titanium (implant, abutment), complying with ASTM F067 and ASTM F0136-2a. Individual aesthetic abutment from CERAMICOR® (gold-platinum alloy). Locator® impression coping from Aluminum Alloy 6061. Surface: Blasted with aluminum oxide particles and then acid-etched for micro-roughness. Performance: Stability of implant body and thread tested via fatigue testing (ISO 14801) and bench testing with an animal model. Tests performed with precursor REVOIS® with comparable results.
Safety and Effectiveness	Must be as safe and effective as the predicate device.	"The differences outlined in the SE comparison evaluation/discussion between the REVOIS® system and the predicate device, do not affect the safety or effectiveness of the REVOIS® PRO Implant System." (Based on comparative analysis and non-clinical testing data listed).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of this 510(k) summary for a dental implant. The "test set" here refers to non-clinical performance testing of mechanical properties:
- Fatigue Testing was done according to ISO 14801. The standard specifies the number of samples required for fatigue testing, which typically involves a set number of test pieces (e.g., 5-10 samples per condition) to establish fatigue limits. The exact number of implants tested is not specified in the summary but would follow the ISO standard.
- Bench Testing with Animal Model was also performed. The summary does not specify the number of animals or implants used in this animal model bench test.
Data Provenance: The document does not explicitly state the country of origin for the non-clinical tests' data, nor whether it was retrospective or prospective. Given that RIEMSER Arzneimittel AG is a German company, it's highly probable the testing was conducted in Germany or Europe. Non-clinical tests like fatigue testing are inherently prospective at the time of execution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable to this 510(k) summary. The "ground truth" for a dental implant system like this is established through objective engineering and biological testing (mechanical fatigue, biocompatibility, and animal/human clinical studies for osseointegration and loading), not expert consensus on image interpretation or diagnostic accuracy. The listed studies (e.g., FRIATEC, 1998; Cia et al., 2003) are scientific publications and clinical trials, where the "ground truth" for success or failure would be determined by clinical outcomes, radiographic assessment, or histological analysis, as defined by the methodologies of those studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. This is not a study assessing diagnostic accuracy requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental implant, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a dental implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the REVOIS® PRO Implant System, the "ground truth" for its performance and safety is derived from:

Mechanical Integrity/Fatigue Testing: Compliance with ISO 14801 standards, which inherently defines "ground truth" for mechanical performance.
Biocompatibility: Conformance to ASTM material standards (ASTM F067, ASTM F0136-2a).
Bench Testing with Animal Models: Histological and biomechanical outcomes observed in animal models (e.g., osseointegration, bone-implant contact) serve as a form of "ground truth" for biological response before human trials.
Clinical Outcomes Data (from referenced studies): The numerous referenced studies (e.g., Cia et al., 2003; Striezel et al., 1998) would have established their "ground truth" through clinical success rates, survival rates, bone loss measurements, clinical evaluations by dentists/surgeons, and patient outcomes over time.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical dental implant, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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REVOIS®: PRO 510(K)-Summary

Section 5 RIEMSER /

	Traditional 510 (k) Summary:	MAY	3 2013
	REVOIS® PRO Implant System
1. SUBMISSION INFORMATION
Name and Address of the Sponsor:	RIEMSER Arzneimittel AGAn der Wiek 717493 Greifswald-Insel RiemsGermany
Date created:	April 19th 2013
Submitter:	Andreas Püttner, PhDHead of Regulatory AffairsTel.: +49 - 69 - 95092-778Fax: +49 - 69 - 95092-779Email: dr.puettner@riemser.com
Contact person:	Riemser Arzneimittel AGChristoph WahlStaff Regulatory affairs dental medical devicesEmail: wahl@riemser.comTel.: +49 38351 76-667Fax: +49 38351 76-778
2. DEVICE IDENTIFICATION
Proprietary Name:	REVOIS® PRO Implant System
Common Name:	Dental implant system, dental implant abutment
Classification Name:	Endosseous Dental Implant, root-form andEndosseous dental implant abutment
Classification:	Class II, Special Controls
Classification regulation Number:	21CFR 872.364021CFR 872.3630

Product Code:	DZA, Endosseous implant
Subsequent Product Code:	NHA, Endosseous implant abutment

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1135.39

Section 5

REVOIS®: PRO 510(K)-Summary

3. PREDICATE DEVICES

REVOIS® Implant System: K063106

4. DESCRIPTION OF THE DEVICE

The REVOIS® PRO Implant System is a development of the former REVOIS® Implant System. The REVOIS® PRO 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 dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently:

Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5
Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5
Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy
Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5 ।
Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5 ।
Locator* abutment, made of Titanium Grade 5 t
Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5
Locator® impression coping, made of the Aluminium Alloy 6061 ।
Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium । Grade 5

The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106.

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1 - 14	Section 5
510/K)-Summarv------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

ડ. STATEMENT OF INTENDED USE

The basis for the substantial equivalence of the REVOIS® PRO Implant System is the following:

The REVOIS® PRO Implant System is an implant system recommended for surgical placement in the edentulous or partly edentulous jaw bone (upper and 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 (with good primary stability and appropriate occlusal loading) in a two-stage surgical procedure (after osseointegration of the implant).

6. STATEMENT OF TECHNOLOGICAL COMPARISON

The REVOIS® PRO Implant System provides state-of-the art implant technology and options that are comparable to the technology of the predicate devices. The innovative design (cvlindrical form of implant, double thread of the implant body turns into a fine thread in the neck of the implant) and pre-assembled version of implant, abutment (which fits for all implants and implant diameters) offers 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 geometric design of the implant is with cylindrical shape and rounded apex.

Compared with the predecessor REVOIS® Implant System, the screw thread of the REVOIS® PRO Implant System covers only about two thirds of the implant, the upper third of the extension of the implant is covered by the mentioned fine thread. The proximal end of the thread is a circumferential crease.

The stability of the implant body and the thread of the REVOIS®: PRO implant system was tested in non-clinical performance testing as Fatigue Testing with mounted standard abutment according to ISO 14801 and Bench Testing with Animal Model. All the tests were also performed with the precursor system REVOIS® with comparable results. The critical appreciation within the clinical assessment was done with the following non-clinical testing data to support this submission: FRIATEC, 1998: Cia et al., 2003; Striezel et al., 1998; Mathew et al., 2000; Jonas et al., 2001; Steigenga et al., 2004; Steigenga et al., 2003; Steigenga et al., 1999; Jalbout et al., 2004; Jividen et al., 2000; Massaro et al., 2002; Gross et al., 1998; Burgess et al. 1999; Chen et al., 2004; Elagli et al., 1989; Hemmerle et al., 1996; Pohler, 2000; Valesco- Ortega et al., 2010;

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REVOIS®: PRO	Section 5
510(K)-Summary	Image: RIEMSER logo

Zaffe et al., 2003; Guizzardi et al., 2004; Shirakura et al., 2003 Esposito et al., 1998; Elagli et al., 1992; Rosengren et al., 2002; Sicilia A. et al., 2008; Kumazawa et al., 2002; Assad et al., 1999.

Additional substantial equivalence results in equivalence to a variety of currently marketed and cleared dental implants or implant systems, especially the REVOIS® Implant System.

Both systems feature root form, screw type, endosseous implants made of titanium, and corresponding 510(K)-exempted tools, instruments and partly 510(K)-exempted accessories. Color coding of components is used in all systems compared for this submission to simplify identification and prevent mix-up of non-coordinating parts. The systems are essentially similar regarding intended use, indications, target population, anatomical sites, implant diameters and lengths, implant to abutment connection, materials used and performance aspects. In addition both systems presented have a treated, roughened surface and tapered parts of the implant bodies. A one-stage or two-stage surgical procedure is possible with the REVOIS® PRO system and the predicate device.

The differences outlined in the SE comparison evaluation/discussion between the REVOIS® system and the predicate device, do not affect the safety or effectiveness of the REVOIS® PRO Implant System.

The REVOIS® system is indeed similar or equivalent, in most compared specifications (Classification, Classification Product Code, Intended Use, Indications for Use, Target population, Anatomical sites, Materials, Implant to abutment connection, Implant diameters, Implant lengths, Identification, Biocompatibility, Compatibility with the environment and other devices, Where used, Human factors, Design, Thread design, Performance, Technology, Standards met, Sterility, Mechanical safety) regarding design and performance even identical enough, to serve as predicates, but the REVOIS® PRO Implant System does have certain advantages of design and technology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

May 3, 2013

Mr. Christopher Wahl Riemser Arzneimittel AG An der Wiek 7 Greifswald-Insel Riems Mecklenburg-Vorpommern 17493 GERMANY

Re: K113539

Trade/Device Name: REVOIS® PRO Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 25, 2013 Received: April 29, 2013

· Dear Mr. Wahl:

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 fiability 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. Wahl

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.

Kwame O. Ulmer -S
FDA

for

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 4.

510(k) Number (if known): K113539

REVOIS® PRO Implant System Device Name:

Indications for Use:

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 -S	Digitally signed by Mary S. Runner -SDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Mary S. Runner -0.9.2342.19200300.100.1.1=1300087950Date: 2013.05.03 15:35:11 -04'00'
-------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K113539
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	Page 1 of 1
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Regulation Number and Section

§ 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.