The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla.

Device Description

The Lifecore Single Tooth Abutment System is designed for use with an endosseous dental implant and provides support and retention for cement-retained, single tooth restorations in the mandible or maxilla. The system consists of the single tooth abutments, abutment screws, healing caps, impression posts, and associated laboratory components. Most components are packaged separately to allow the clinician to choose only those components required for each clinical situation. The Lifecore Single Tooth Abutment System has been designed to be dimensionally compatible with the Nobel Biocare CeraOne® Abutment System gold and ceramic sleeves. The single tooth abutments and healing caps are manufactured from titanium allov (Ti 6Al-4V E.L.I.).

AI/ML Overview

This document describes a 510(k) premarket notification for the "Lifecore Single Tooth Abutment System". This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through a clinical study with acceptance criteria.

Therefore, the requested information elements related to acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC/standalone studies are not applicable in this context.

Here's an explanation based on the provided document:

The 510(k) submission (K993894) for the Lifecore Single Tooth Abutment System is a premarket notification aiming to demonstrate substantial equivalence to legally marketed predicate devices. This regulatory pathway does not typically involve setting acceptance criteria and conducting studies to prove the device meets those criteria in the same way a de novo device would for establishing safety and effectiveness. Instead, it relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.

Here's what the document does provide relevant to your request:

Type of Study Conducted: This was a nonclinical study focused on demonstrating dimensional compatibility and material properties. The document states:
- "The Lifecore Single Tooth Abutment System has been tested to ensure that all design specifications have been met."
- "Dimensional inspections are routinely performed."
- "Electrochemical Corrosion Evaluation... has been performed..."
- "To ensure the Lifecore Single Tooth Abutment System design is compatible with the Nobel Biocare CeraOne® Abutment System Ceramic and Gold Sleeves, the critical mating dimensions of the CeraOne abutment, ceramic, and gold sleeves were measured using a Mycrona Video Measuring Machine and micrometers."
Implicit "Acceptance Criteria" (based on equivalence): While not explicitly stated as "acceptance criteria" for performance, the goal of the nonclinical tests was to show that:
- Design specifications were met.
- Corrosion properties were "within acceptable limits" when exposed to artificial saliva.
- Dimensions were compatible with the predicate Nobel Biocare CeraOne® Abutment System Ceramic and Gold Sleeves, meaning the Lifecore system was designed to "match or to be within the dimensional ranges identified" from the predicate device.
Data Provenance: The data is internally generated from Lifecore Biomedical, Inc. based on their testing, and it is "retrospective" in the sense that it's a submission for a new device based on existing technological understanding and comparison to already marketed devices. The country of origin of the data would be the USA (Lifecore Biomedical, Inc. is located in Chaska, MN, USA).
Ground Truth: For the nonclinical tests, the "ground truth" was established by engineering specifications, material science standards, and measurements of the predicate device's dimensions.

Why the other points are not applicable:

Table of acceptance criteria and reported device performance: Not provided because this isn't a performance study against specific clinical criteria.
Sample size for test set and training set, data provenance (for clinical data): No clinical test set or training set for an AI/algorithm is described. The "test set" here refers to the physical components tested for dimensional compatibility and corrosion.
Number of experts and qualifications, adjudication method: Not relevant as this is not a diagnostic device involving expert interpretation of results.
MRMC comparative effectiveness study: Not conducted, as this is a dental implant component, not a diagnostic algorithm where human readers assess performance.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
Type of ground truth (e.g., pathology, outcomes data): While real-world outcomes are the ultimate measure of clinical success for implants, for a 510(k) for an abutment, "ground truth" for the nonclinical tests is based on engineered specifications and comparison to predicate device characteristics.
How ground truth for the training set was established: No training set in the context of AI/machine learning.

In summary, the provided document describes a 510(k) submission where substantial equivalence is demonstrated through nonclinical testing (dimensional compatibility, material characteristics) rather than clinical performance studies with predefined acceptance criteria for a novel therapeutic or diagnostic outcome.

Summary

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KA93894

Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Carolyn Anderson Regulatory Specialist Lifecore Biomedical, Inc. 3515 Lyman Blvd. Chaska, MN 55318 612-368-6324 Ph: Fax: 612-368-4278.

2. General Information

Trade Name	Lifecore Small Diameter (SD) Single Tooth Abutmentwith cuff heights of 1mm, 2mm, 3mm, and 4mm Lifecore Regular Diameter (RD) Single ToothAbutment with cuff heights of 1mm, 2mm, 3mm, and4mm Lifecore Wide Diameter (WD) Single Tooth Abutmentwith cuff heights of 1mm, 2mm, 3mm, and 4mm Lifecore SD / RD Healing Cap for the Single ToothAbutment with flare diameters of 5.0mm, 6.0mm, and7.5mm Single Tooth Abutment Screw, Square, Gold (in SD,RD, and WD sizes) Single Tooth Abutment Screw, .048" Hex, Titanium(in SD, RD, and WD sizes Lifecore WD Healing Cap for the Single ToothAbutment with flare diameters 6.0mm and 7.5mm
Common / UsualName	Single Tooth Abutment
Classification Name	Precision Attachment for use as an accessory for ClassIII Endosseous Implants (per 21 CFR 872.3165)
Identification ofEquivalent Devices	Single Tooth Abutment System (STA™) (K965077),manufactured by Implant Innovations, and CeraOne®Abutment System (K910611), manufactured by NobelBiocare

3. Device Description

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clinician to choose only those components required for each clinical situation. The Lifecore Single Tooth Abutment System has been designed to be dimensionally compatible with the Nobel Biocare CeraOne® Abutment System gold and ceramic sleeves. The single tooth abutments and healing caps are manufactured from titanium allov (Ti 6Al-4V E.L.I.).

4. Intended Use

The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla.

5. Technological Characteristic Comparisons

The Lifecore Single Tooth Abutment System is substantially equivalent to the Single Tooth Abutment System (K965077), manufactured by Implant Innovations and the CeraOne® Abutment System (K910611), manufactured by Nobel Biocare. Compared to the predicate devices, the Lifecore Sinqle Tooth Abutment System has the same intended use, all systems are intended to be used for single tooth restorations. In addition, both the Lifecore and predicate abutment systems utilize similar designs, materials, and accessories.

6. Nonclinical Tests

The Lifecore Single Tooth Abutment System has been tested to ensure that all design specifications have been met. Dimensional inspections are routinely performed, Electrochemical Corrosion Evaluation of Uncoupled and Coupled Implant and Restorative Alloys has been performed to determine corrosion properties when exposed to artificial saliva and to determine the galvanic corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Ti-6Al-4V galvanic couples. All have been found to be within acceptable limits.

To ensure the Lifecore Single Tooth Abutment System design is compatible with the Nobel Biocare CeraOne® Abutment System Ceramic and Gold Sleeves, the critical mating dimensions of the CeraOne abutment, ceramic, and gold sleeves were measured using a Mycrona Video Measuring Machine and micrometers. The dimensional range for each component was determined. The Lifecore Single Tooth Abutment and Single Tooth Gold Sleeve were designed to match or to be within the dimensional ranges identified.

7. Substantial Equivalence Comparison

The Lifecore Single Tooth Abutment System is substantially equivalent to the following products:

3i single Tooth AbutmentSystem (STA or ST Abutment)	Nobel Biocare CeraOneAbutment System
Implant Innovations, Inc.4555 Riverside Dr.Palm Beach Gardens, FL 33410	Nobel Biocare333 West Wacker Dr.Suite 2600Chicago, IL 60606
Premarket Notification Number:K965077	Premarket Notification Number:K910611

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8. Conclusion (statement of equivalence)

The data submitted in this 510(k) is in support of substantial equivalency of Lifecore Single Tooth Abutment System to the following commercially marketed devices:

3i Single Tooth Abutment System (STA™) (K965077) .
Nobel Biocare CeraOne® Abutment System (K910611) .

These current products as defined by their product literature, demonstrate the basis for the substantial equivalency relative to indications, materials, and design. The intended use of these devices is the same as the Lifecore Single Tooth Abutment System. The compatibility analysis demonstrates the substantial equivalence of Lifecore Single Tooth Abutment System to the predicate devices that are in commercial distribution.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines, possibly representing people or services provided by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2000

Ms. Carolyn Anderson Regulatory Specialist Lifecore Biomedical, Inc. 3515 Lyman Boulevard Chaska, Minnesota 55318-3051

Re : K993894 Lifecore Single Tooth Abutment System Trade Name: Regulatory Class: III Product Code: DZE - Dated: February 33, 2000 ۾

Received: February 25, 2000

Dear Ms. Anderson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Eederal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 -Ms. Anderson

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): h093894

Device Name: Lifecore Single Tooth Abutment System

Indications for Use:

The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla. 1. 1. ، --------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

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.