The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

Device Description

The RePlus Implant system consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are coated with the same soluble blast media (SBM) blasted surface treatment or HA plasma sprayed. The HA coated variety of these implants are the subject of this submission.

AI/ML Overview

The provided document is a 510(k) summary for the RePlus Dental Implants With HA Coating. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

Device Description: Tapered screw-type endosseous implants with specific thread configurations, materials (medical grade titanium alloy), and surface treatments (SBM blasted or HA plasma sprayed).
Intended Use: For use in mandible and maxilla to support single or multiple-unit restorations and for retention/support of overdentures, including immediate loading under specific conditions.
Device Comparison: States that the device compares favorably to predicate devices (Zimmer Dental Tapered Screw-Vent, Nobel Biocare Tapered Groovy Implants, and Implant Direct's Spectra-System) in function, technological characteristics, intended use, and materials.
Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, which allows the device to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided text.

To answer your specific questions, if such a study were to be described, it would typically include details like:

A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative targets (e.g., bone-to-implant contact percentage > X%, maximum torque value > Y Ncm) and the results obtained from testing.
Sample size used for the test set and the data provenance: How many implants were tested, where were they tested (e.g., specific clinics, animal models), and was the data collected retrospectively from existing records or prospectively through a new study?
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would apply more to image-based diagnostic devices, not typically for dental implants.
Adjudication method: Again, more relevant to diagnostic interpretations.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not typically applicable for dental implants, which are hardware devices.
Standalone performance: Also not applicable as this relates to an algorithm's performance without human interaction.
Type of ground truth used: For dental implants, ground truth often relates to histological measurements of bone integration, mechanical stability testing, or clinical follow-up data on success rates.
Sample size for the training set: Not applicable for a device like a dental implant; this refers to AI/machine learning models.
How the ground truth for the training set was established: Not applicable for a dental implant.

Based on the provided text, the RePlus Dental Implants With HA Coating achieved market clearance through a 510(k) submission by demonstrating substantial equivalence to existing predicate devices, rather than through a study proving it met specific novel acceptance criteria. Substantial equivalence means the device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Summary

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MAR - 7 2008

RePlus Dental Implants With HA Coating Traditional 510(K) Submission

510(K) Summary (21CFR 807.92(a))

1. Submitter's Information Company Name: Implant Direct LLC Address: 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Telephone Number: 818-444-3300 Fax Number: 818-444-3400 Registration Number: 3001617766 Contact Person: Tom Gottenbos Date Summary Prepared: October 11, 2007 Classification Name: Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant
1. Device Trade Name: RePlus Dental Implants With HA Coating
Predicate Device(s); Zimmer Dental Tapered Screw-Vent Dental Implants 3. (K013227), Nobel Biocare Tapered Groovy Implants (K29352) and Implant Direct's Spectra-System (K061319)

4. Device Description:

ર. Intended Use:

Device Comparison: 6.

RePlus System Dental Implants With HA Coating compare favorably to similar devices found within the cited predicates. The implants within this submission are used in an identical function as the cited predicates. The implants within this submission have nearly identical technological characteristics, intended use, and materials used in manufacture as the cited predicates

Image /page/0/Picture/14 description: The image shows the logo for Implant Direct LLC. The logo features a stylized letter "D" with a circle at the top, followed by the words "Implant Direct LLC" in a bold, sans-serif font. Below the company name is the website address, "www.implantdirect.com".

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

Mr. Thomas Gottenbos Vice President of I'/Regulatory Affairs Implant Direct LLC 27030 Malibu Hills Road Calabasas Hills, California 91301

Re: K073161

Trade/Device Name: RePlus Dental Implants With HA Coating Regulation Number: 21 CFR 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 28, 2008 Received: February 29, 2008

Dear Mr. Gottenbos:

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. Gottenbos

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutie y. Michie m.d.

Chiu Lin, Ph.D. 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 (if known): K073161

Device Name: RePlus Dental Implants With HA Coating

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Svan Kumer

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

Page 1 of 1

:10(k) Number: 607316

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.