The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.

Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.

Device Description

The Legacy Abutment System consists of cement retained and screw-retained components. All abutments have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants manufactured by Zimmer Dental. The cement retained abutments are offered in a straight body with a straight or scalloped prosthetic margin and in an angled body with a scalloped prosthetic margin. The screw-retained abutments are offered in different cuff diameters and heights to accommodate for the different implant interfaces and tissue heights.

AI/ML Overview

This document is a 510(k) summary for the Legacy Abutment System, which is a dental implant abutment. The purpose of this summary is to demonstrate substantial equivalence to a predicate device, the Screw-Vent Dental Implant System (K011028).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific quantitative "acceptance criteria" for a study in the typical sense of a diagnostic device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it presents a comparison analysis to a predicate device, highlighting "technological characteristics" as the basis for demonstrating substantial equivalence. The "performance" here is that the Legacy Abutment System possesses similar characteristics and intended use to the legally marketed predicate device.

Technological Characteristic	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Legacy Abutment System)
Intended Use	To be used as a post to support cemented/screw-retained prostheses for crowns, bridges, or overdentures in edentulous or partially edentulous patients.	Same as predicate. (Supports crowns, bridges, or overdentures for edentulous or partially edentulous patients; functions as a foundation for cemented/screw-retained restorations.)
Indication	For single or multiple restorations.	Same as predicate. (For single or multiple restorations; multiple unit application for screw-retained.)
General Design (Straight/Scalloped)	Hex engaging post without a prosthetic margin.	Hex engaging post with a prosthetic margin. (A minor difference noted, but overall design is "similar" and still deemed substantially equivalent for its function.)
General Design (Angled)	Hex engaging angled post without prosthetic margin.	Hex engaging angled post with a prosthetic margin. (A minor difference noted, but overall design is "similar" and still deemed substantially equivalent for its function.)
General Design (Screw-Retained)	One-piece abutment that screws inside the implant.	Same as predicate.
Cuff Diameters (Straight/Scalloped)	3.5, 4.5, 5.7, and 6.5 mm.	4.5, 5.7, and 6.5 mm. (Fewer options than predicate, but within a similar range used to support equivalence.)
Implant/Abutment Interface Diameters	3.5, 4.5, and 5.7mm.	Same as predicate.
Material	Titanium Alloy.	Same as predicate.
Packaging (Straight/Scalloped)	Screw mount inside a vial closed with a cap.	Scalloped: Screw mount inside a vial closed with a cap. Straight: Abutments attached to a plastic transfer/holder engaged within an inner vial, which along with a screw-mount containing temporary coping, is placed within a larger outer vial and closed with a cap. (Different, but deemed acceptable.)
Packaging (Angled)	Screw mount inside a vial closed with a cap.	Same as predicate.
Packaging (Screw-Retained)	Screw mount inside a vial closed with a cap.	Attached to a plastic transfer/holder engaged within an inner vial. The inner vial, along with a screw-mount containing the temporary coping, will be placed within a larger outer vial and closed with a vial cap. (Different, but deemed acceptable.)
Sterilization	Sterile.	Non-sterile. (A notable difference from the predicate, but acceptable given the nature of the device and likely requiring sterilization by the end-user. This is addressed as not raising additional safety/effectiveness concerns in the conclusion.)
Compatibility	Compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.	Same as predicate. (The Legacy Abutment System is designed to have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants). The manufacturer commits to monitoring compatible implants for future modifications.

Study That Proves the Device Meets Acceptance Criteria:

The "study" presented here is a comparison analysis to a legally marketed predicate device (Screw-Vent Dental Implant System, K011028), rather than a clinical trial or performance study typical for novel devices or software. The conclusion states: "The evaluation of the Legacy Abutment System does not raise any additional concerns regarding safety and effectiveness and therefore is considered substantially equivalent to the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of a dataset for an AI/algorithm, nor does it refer to patient data or a clinical study. The "test" for substantial equivalence is a comparison of product characteristics. Therefore, there is no sample size for an AI test set or specific data provenance information (country of origin, retrospective/prospective). The data provenance is essentially the technical specifications and design characteristics of the Legacy Abutment System and the predicate device.

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

Not applicable. This is not a study assessing diagnostic performance where expert ground truth is established. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device, as determined by its FDA clearance. The "experts" involved are likely the engineering and regulatory teams at Implant Direct LLC and ultimately the FDA reviewers (e.g., Chiu Lin, Ph.D., Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) who determined the substantial equivalence. Their qualifications are inherent in their roles within these organizations.

4. Adjudication Method for the Test Set

Not applicable. There is no multi-reader or adjudication process described as this is not a diagnostic performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (dental abutment), not an AI algorithm. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study for an algorithm was not done. This submission is for a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the legally marketed predicate device (Screw-Vent Dental Implant System, K011028). The new device is evaluated against the established characteristics and intended use of this predicate to determine substantial equivalence, rather than against a specific pathology or clinical outcome dataset for novel performance claims.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm submission that would involve a training set.

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

Not applicable, as there is no training set mentioned in the context of an AI device.

Summary

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Image /page/0/Picture/0 description: The image is a logo for Implant Direct LLC. The logo features a large letter "D" with a dental implant integrated into the left side of the "D". To the right of the "D" is the text "Implant Direct LLC" in a bold, sans-serif font. Below the logo is the website address "www.implantdirect.com".

06 0063

CONFIDENTIAL Legacy Abutment System

K.V. + 0.0006

510(K) SUMMARY

Company Name: Implant Direct LLC Address: 27030 Malibu Hills Road Calabasas Hills CA 91301 Telephone Number: (818) 444-3300 Fax Number: (818) 444-3408 Registration Number: 3001617766 Submitter's Name: Leslie Terry Contact Person: Patty McMahon Date Summary Prepared: January 5, 2006 - amended May 3, 2006

Classification Name: Abutment, Implant, Dental, Endosseous Common/Usual Name: Endosseous dental implant abutment Device Trade Name: Legacy Abutment System

The primary device used for comparison in this summary is the Screw-Vent Dental Implant System (K011028).

1. Description:

2. Intended Use:

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3. Technological Characteristics:

The Legacy abutments provide support for crowns, bridges, or overdentures in edentulous or partially edentulous patients for cement retained and screw retained restorations following the same preparation principals as the predicate devices. The Legacy abutments have similar technological characteristics and the same intended use as the predicate device. The Legacy abutments are packaged non-sterile for sale unlike the predicate devices packaged sterile. The Straight, Scalloped, and Angled Abutments are designed to function as a foundation for cemented restorations. The Screw-Retained abutments are designed to function as a foundation for scrow-retained restoration.

4. Comparison Analysis:

The overall designs of the Legacy Abutment System are similar to the predicate devices. The following Tables 1, 2, 3 summarize the predicate device comparison analyses with the Legacy Abutments.

TechnologicalCharacteristics	Legacy Straight and ScallopedAbutments	Predicate Device:Screw Vent Dental ImplantSystem (K011028)
Intended Use	To be used as a post to support thecemented prostheses	To be used as a post tosupport the cementedprostheses
Indication	For single or multiple restorations	For single or multiplerestorations
General Design	Hex engaging post with a prostheticmargin	Hex engaging post without aprosthetic margin
Cuff Diameters	4.5, 5.7, and 6.5 mm	3.5, 4.5, 5.7, and 6.5 mm
Implant/abutmentInterfacediameters	3.5, 4.5, and 5.7mm	3.5, 4.5, and 5.7mm
Material	Titanium Alloy	Titanium Alloy
Packaging	Scalloped Abutments: Screw mountinside a vial closed with a capStraight Abutments:The abutments are attached to aplastic transfer/holder engaged withinan inner vial. The inner vial, alongwith a screw-mount containing thetemporary coping, will be placedwithin a larger outer vial and closedwith a vial cap.	Screw mount inside a vialclosed with a cap
Sterilization	Non-sterile	Sterile

Table 1: Legacy Cement Retained Straight and Scalloped Abutments

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TechnologicalCharacteristics	Legacy Angled Abutments	Predicate Device:Screw Vent Dental ImplantSystem (K011028)
Intended Use	To be used as a post to support theprostheses	To be used as a post tosupport the prostheses
Indication	For single or multiple restorations	For single or multiplerestorations
General Design	Hex engaging angled post with aprosthetic margin	Hex engaging angled postwithout prosthetic margin
Material	Titanium Alloy	Titanium Alloy
Packaging	Screw mount inside a vial closed witha cap	Screw mount inside a vialclosed with a cap
Sterilization	Non-sterile	Sterile

Table 2: Legacy Cement Retained Angled Abutments

Table 3: Legacy Screw Retained Abutments

TechnologicalCharacteristics	Legacy Screw-Retained Abutments	Predicate Device:Screw Vent Dental ImplantSystem (K011028)
Intended Use	Screw retained restoration	Screw retained restoration
Indication	Multiple unit application	Multiple unit application
General Design	One-piece abutment that screws inside the implant	One-piece abutment that screws inside the implant
Material	Titanium Alloy	Titanium Alloy
Packaging	Attached to a plastic transfer/holder engaged within an inner vial. The inner vial, along with a screw-mount containing the temporary coping, will be placed within a larger outer vial and closed with a vial cap	Screw mount inside a vial closed with a cap
Sterilization	Non-sterile	Sterile

5. CONCLUSION

The evaluation of the Legacy Abutment System does not raise any additional concerns regarding safety and effectiveness and therefore is considered substantially equivalent to the predicate device.

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the HHS logo, which is a stylized caduceus. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are written around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 2006

Ms. Leslie Terry Implant Direct, LLC 27030 Malibu Hills Road Calabasas Hills, California 91301

Re: K060063

Trade/Device Name: Legacy Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental implant Regulatory Class: II Product Code: NHA Dated: May 3, 2006 Received: May 4, 2006

Dear Ms. Terry:

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 - Ms. Terry

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,

Chi-Lien, Ph.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): K060063

Device Name: Legacy Abutment System

Indications for Use:

X Prescription Use (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 IF NEEDED)

Susan Kunn
Vision Sign-Off

investion of Anesthesiology, Genemaldessives, of CDRH, Office of Device Evaluation (ODE) Infaction Control, Dental Devices

Number: 185600623

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)