Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Device Description

The Uniplant Dental Implant System is composed of a solid titanium alloy root-form implant and a solid conical abutment, with associated instruments. The implant is a screw-type, two-stage design, incorporating a titanium cover screw that seals the internal bore of the implant from the physiologic environment during healing. The implant is available in three diameters (3.4, 4.1 and 5.1 mm) and three implanted lengths (10 mm, 12 mm and 14 mm). The system includes surgical instruments such as drills, insertion modules and try-ins. The system includes a solid conical abutment that is intended to the implant by engaging the threaded shaft of the abutment in the internal threaded bore of the implant. The abutment includes a cylindrical transmucosal portion and a tapered, grooved coronal portion, with an internal hex socket at the coronal end to facilitate attachment to the implant. A prosthesis may be fabricated by means of standard crown and bridge techniques for attachment to the abutment.

AI/ML Overview

The provided text is a 510(k) summary for the Uniplant Dental Implant System from 2001. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in the provided document. The 510(k) process for this device relies on demonstrating similarity to existing devices for which safety and effectiveness have already been established.

However, I can extract the information related to substantial equivalence, which is the core of this document.

Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) given the nature of a 510(k) submission for this type of device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: N/A. This document does not define specific performance acceptance criteria for the Uniplant Dental Implant System in the way a clinical study would with primary endpoints (e.g., success rates, failure rates, stability metrics). Instead, it demonstrates that the device's characteristics are comparable to predicate devices.
Reported Device Performance: N/A. The document does not report specific device performance data from clinical trials with numerical outcomes. It asserts equivalency in design and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. No clinical test set or data provenance is mentioned. The submission is based on a comparison to existing devices and their known characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No test set requiring adjudication is described.

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

N/A. This is a medical device (dental implant), not an AI-driven diagnostic tool. Therefore, an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. Not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. No specific ground truth is established for this device. The basis for approval is substantial equivalence to predicate devices, whose safety and effectiveness are established through their existing market history and previous regulatory clearances.

8. The sample size for the training set

N/A. Not an AI algorithm.

9. How the ground truth for the training set was established

N/A. Not an AI algorithm.

Summary Table of Substantial Equivalence (as provided in the document):

This table demonstrates the basis for regulatory acceptance, which is equivalence to previously approved devices, rather than a clinical study's acceptance criteria.

Characteristic	Uniplant Dental Implant System (Subject Device)	Predicate Devices (Examples given in the table)
INTENDED USE
Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients	YES	YES
DESIGN
Body shape	cylindrical	cylindrical ("O" Company, Simpler), tapered (Steri-Oss)
Surface design	threaded	threaded
Single-stage or two-stage design	two-stage	two-stage ("O" Company, Steri-Oss), single-stage or two-stage (Simpler)
Method of abutment attachment to implant	threaded connection	threaded connection ("O" Company, Simpler), screw (Steri-Oss)
Available diameters, mm	3.4, 4.1, 5.1	3.25, 4.0 ("O" Company, Simpler), 6.0, 5.0, 4.3 (Steri-Oss)
Available lengths, mm	10, 12, 14	8, 10, 12, 14, 16 ("O" Company), 10, 13, 16 (Steri-Oss), 8, 10, 13, 15 (Simpler)
Solid abutment for cemented restorations	YES	YES
MATERIALS
Implant body	Ti-6Al-4V	CP Ti ("O" Company, Steri-Oss), Ti-6Al-4V (Simpler)
Abutment	Ti-6Al-4V	Ti-6Al-4V ("O" Company, Simpler), Ti alloy (Steri-Oss)
Surface characteristics / coating	RBM or HA	Machined or HA ("O" Company), HA (Steri-Oss), Grit blasted or HA (Simpler)

Study Proving Device Meets Acceptance Criteria:

The document describes a substantial equivalence review rather than a specific clinical study to prove the device meets pre-defined acceptance criteria for performance.

Study Type: Substantial Equivalence Comparison.
Methodology: The manufacturer compared the Uniplant Dental Implant System to three established predicate devices (products from "O" Company, Steri-Oss Replace, and Simpler Implant System) that had already demonstrated safety and effectiveness and were legally marketed. The comparison was based on:
- Intended Use: All devices shared the same intended use for surgical placement to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
- Design and Functional Characteristics: Similarities in root-form threaded design, two-stage configuration, and abutment attachment methods were highlighted. Variations in dimensions (diameters, lengths) were noted, but within the scope of predicate devices.
- Material Composition: Comparison of implant and abutment materials (Ti-6Al-4V, CP Ti) and surface treatments (HA coating, RBM treatment) to those of the predicate devices, emphasizing the widespread and biocompatible nature of these materials. The HA coating's characteristics were also compared to vendor master files and FDA Guidance Document suggestions for crystallinity, purity, and mechanical properties.
Conclusion of the Review: The FDA's letter (K011574) states, "We have reviewed your Section 510(k) notification... and we have determined the device... is substantially equivalent to legally marketed predicate devices." This determination signifies that based on the provided comparison, the device is considered as safe and effective as the predicate devices, without requiring new clinical performance data.

Summary

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Uniplant Dental Implant System

Page 1

ADMINISTRATIVE INFORMATION SEP 2 8 2001 Manufacturer Name: Universal Implant Systems, Inc. 1301 Ynez Place Coronado, CA 92118 Official Contact: Robert F. Mansueto, D.D.S. Telephone (619) 435-6227 FAX (619) 435-4717 Representative/Consultant: Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, CA 92130 Telephone: (858) 792-1235 FAX: (858) 792-1236 E-mail: flarson@paxmed.com DEVICE NAME Classification Name: Endosseous dental implant

Common Name:

Trade/Proprietary Name:

Dental Implant

Uniplant Dental Implant System

ESTABLISHMENT REGISTRATION NUMBER

Universal Implant Systems, Inc. is not yet registered with FDA.

DEVICE CLASSIFICATION

Endosseous dental implants have been classified by FDA as Class III devices under a final order published in the Federal Register of August 12, 1987, as shown in 21 CFR 872.3640. Abutments to such implants are considered by FDA to be Class III devices inasmuch as they are used as accessories to or are used with endosseous dental implants. The device is reviewed by the Dental Products Panel and the Product Code for the device is DZE.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514. Voluntary standards with which the Uniplant Dental Implant System complies include American Society for Testing and Materials (ASTM) designation F1472 (Standard Specification for Wrought Titanium 6Al-4V Alloy for Surgical Implant Applications (UNS R56400)) and ASTM F1609 (Standard Specification for Calcium Phosphate Coatings for Implantable Materials).

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510(k) Summary

PACKAGING/LABELING/PRODUCT INFORMATION

Advertising material to be used for promotion of the Uniplant Dental Implant System will be consistent with the indications for use and other material shown herein.

Uniplant dental implants are packaged in a radiation sterilizable package consisting of an outer tamper evident container and an inner vial of glass or plastic. Sterilization is accomplished by means of Co6 gamma irradiation at a dose of 25 kGy (2.5 Mrad) minimum. Sterilization will be validated by the bioburden method. The sterility assurance level (SAL) that Universal Implant Systems intends to meet for the Uniplant dental implant is 106. The device is not represented to be "pyrogen free." Abutments and instruments will be packaged either sterile in a system similar to the implant packaging or non-sterile in plastic bags.

INTENDED USE

The Uniplant Dental Implant System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

DEVICE DESCRIPTION

Design Characteristics

The system includes a solid conical abutment that is intended to the implant by engaging the threaded shaft of the abutment in the internal threaded bore of the implant. The abutment includes a cylindrical transmucosal portion and a tapered, grooved coronal portion, with an internal hex socket at the coronal end to facilitate attachment to the implant. A prosthesis may be fabricated by means of standard crown and bridge techniques for attachment to the abutment.

Material Composition

Implants and abutments for the Uniplant Dental Implant System are made from titaniumaluminum-vanadium alloy that meets ASTM designation F1472 (Standard Specification for Wrought Titanium -6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R 56400)). Uniplant implants have a smooth machined collar of 1.0 mm height and from that point to the apex are coated with a layer of plasma-sprayed hydroxyapatite (HA) to facilitate attachment of bone. An alternative surface treatment for the Uniplant is a resorbable blast media (RBM) treatment, in which acid soluble grit (hydroxyapatite) is used to roughen the surface in order to facilitate bone attachment. The surface is then treated with acid to remove any residual

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any residual grit particles. The use of titanium, titanium alloy and HA coatings is widespread in commercially distributed, permanently implanted medical devices and the materials are widely considered to be biocompatible. Titanium is often used as a negative control in biocompatibility testing.

EQUIVALENCE TO MARKETED PRODUCT

Universal Implant Systems, Inc. submits the following information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Uniplant Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: "O" Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857).

Intended Uses

The indications for use for the Uniplant Dental Implant System and the predicate devices are substantially the same. All are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Design and Materials

The design and functional characteristics of the Uniplant Dental Implant System and the "O" Company Threaded Implant are similar in their use of a root-form threaded design. The threads are intended to provide macroretention in bone and to increase the surface area for bone attachment relative to a smooth design. The threads of the Steri-Oss Replace implant and the Simpler threaded implant serve a similar function. The "O" Company Implant and Fixed C&B Abutment shares with the Uniplant Dental Implant System the method of attaching the abutment to the implant using a threaded abutment shaft. The Uniplant shares the use of Ti-6Al-4V with numerous marketed implants. It shares the use of an HA coating with the "O" Company Threaded Implant, the Steri-Oss Replace HA-Coated Implant, the Simpler HA-coated cylinder implant and numerous other marketed implants.

Hydroxyapatite Coating Characteristics

The characteristics of the HA coating used on the Uniplant Dental Implant System are shown in vendor master files. The Uniplant Dental Implant System HA coating has crystallinity, purity and mechanical properties at least as high as those of the coatings on currently marketed devices and at least as high as the suggestions of the FDA Guidance Document.

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SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE

The Uniplant Dental Implant System is substantially equivalent to the "O" Company Threaded Implants and Fixed C&B Abutment, the Steri-Oss Replace HA-Coated Implant, and the Simpler Implant System in the following respects:

	SubjectDevice	Predicate Devices
	UniplantDentalImplantSystem	"O" CompanyThreadedImplants(K923889,K950066,K961665,K973926)	Steri-OssReplaceHA-CoatedImplant(K962845)	SimplerImplantSystem(K974401,K974402,K974856,K974857)
INTENDED USE
Surgical placement in the maxillaryand/or mandibular arch to support crowns,bridges, or overdentures in edentulous orpartially edentulous patients	YES	YES	YES	YES
DESIGN
Body shape	cylindrical	cylindrical	tapered	cylindrical
Surface design	threaded	threaded	threaded	threaded orpush-in
Single-stage or two-stage design	two-stage	two-stage	two-stage	single-stage ortwo-stage
Method of abutment attachment toimplant	threadedconnection	threadedconnection	screw	threadedconnection,screw, cement
Available diameters, mm	3.4, 4.1, 5.1	3.25, 4.0	6.0, 5.0, 4.3	3.25, 4.0
Available lengths, mm	10, 12, 14	8, 10, 12, 14,16	10, 13, 16	8, 10, 13, 15
Solid abutment for cemented restorations	YES	YES	YES	YES
MATERIALS
Implant body	Ti-6Al-4V	CP Ti	CP Ti	Ti-6Al-4V
Abutment	Ti-6Al-4V	Ti-6Al-4V	Ti alloy	Ti-6Al-4V
Surface characteristics / coating	RBM orHA	Machined orHA	HA	Grit blasted orHA

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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 symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle symbol is composed of three curved lines representing the wings and body of the eagle.

Public Health Service

SEP 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Universal Implant Systems, Incorporated C/O Mr. Floyd G. Larson Consultant Paxmed International 4329 Graydon Road San Diego, California 92130

K011574 Re : Uniplant Dental Implant System Trade/Device Name: Regulation Number: 872.3640 Regulatory Class: III Product Code: DZE Dated: May 18, 2001 Received: May 22, 2001

Dear Mr. Larson:

We have reviewed your Section 510(k) notification of incent to we have reviewed your referenced above and we have determined the market the device icrores and indications for use device in the enclosure) to legally marketed predicate devices stated in the enously commerce prior to May 28, 1976, the markeed in theorbeat of the Medical Device Amendments, or to devices ehatement ade or lassified in accordance with the provisions of that have been rooman, and Cosmetic Act (Act). You may, the reactar rood, bray, subject to the general controls encreasions of the Act. The general controls provisions of the provibions or chirements for annual registration, listing of Act include roquirefacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be (Spectal controls, or oral controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good equivacins accountice requirements, as set forth in the Quality Manufacturing Fraound for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the (zi Crk Fare Gro, aistration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further regaracery accerning your device in the Federal Register.

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Page 2 - Mr. Larson

Please note: this response to your premarket notification rieast note. Childress any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as first recei will as to (k) premarket notification. The FDA finding acperstantial 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 and additionally 809.10 for in xitro regaroric devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of advertibility of Jour 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). responsibilities under the Act may be obtained from the Division responsiblances 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/dsma/dsmamain.html".

Sincerely yours,

Clus-ton
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K011574

Device Name: Uniplant Dental Implant System

Indications for Use:

Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use $\checkmark$

MCAdyhm fes MSR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Over-The-Counter Use

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.