The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus 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 placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Device Description

The ScrewPlus Implant system consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of minithreads 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

This document is a 510(k) summary for a dental implant system (K073049). It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:

Identical intended use: The ScrewPlus System Implants with HA Coating have the same intended use as the predicate implants (Zimmer Dental AdVent Dental Implant System and Implant Direct's Spectra-System).
Nearly identical technological characteristics and materials: The new device shares the same screw-type design, thread configuration, minithreads, medical-grade titanium alloy, and surface treatment (SBM blasted or HA plasma sprayed) as the predicate devices.

The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This is a regulatory pathway that primarily compares a new device to existing ones rather than detailing performance studies with specific acceptance criteria in the way you've outlined.

Therefore, I cannot populate your requested table and information points as the provided text does not contain that type of data. The document does not describe:

A table of acceptance criteria and reported device performance (e.g., accuracy, sensitivity, specificity).
Sample sizes for test sets or their data provenance.
Number/qualifications of experts for ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance studies.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Implant Direct LLC. The logo features a stylized letter "D" with a screw-like design on the left side. To the right of the "D" are the words "Implant Direct LLC" in a bold, sans-serif font. Below the logo is the website address "www.implantdirect.com".

K073049

Legacy System Dental Implants With HA Coating Traditional 510(K) Submission

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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 DEC 1 3 2007 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: ScrewPlus System Dental Implants With HA Coating
1. Predicate Device(s): Zimmer Dental AdVent Dental Implant System (K012245) and Implant Direct's Spectra-System (K061319)

4. Device Description:

5. Intended Use:

The intended use of the ScrewPlus System Implants with HA Coating is identical to the intended use of the predicate implants. These implants are two-piece implants for single-stage or two-stage surgical procedures. The ScrewPlus 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 placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

6. Device Comparison:

ScrewPlus 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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three abstract figures instead of snakes.

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073049

Trade/Device Name: ScrewPlus Dental Implants With HA Coating Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 19, 2007 Received: October 29, 2007

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,

Syvie Y. Michaudms.

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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K07304/9

Indications for Use

510(k) Number (if known): ___K073049

Device Name: ScrewPlus 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)

Susann

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

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87.1

510(k) Number. K073417

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.