LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.

Device Description

The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner.

The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.

AI/ML Overview

This document describes a medical device submission (K061042) for the LingLock lingual orthodontic retainer. It is a 510(k) summary, which means the manufacturer is claiming substantial equivalence to existing devices, and therefore, an extensive clinical study to prove effectiveness or safety like those required for a PMA (Pre-Market Approval) is typically not required.

Given this context, the document does not describe a detailed study with acceptance criteria and device performance as one might find for a novel or high-risk device requiring extensive clinical trials. Instead, the basis for clearance is substantial equivalence to predicate devices.

Therefore, many of the requested items (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the relevant information regarding the device's intent and the basis for its clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The "acceptance criteria" in a 510(k) context for a device like this are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is "accepted" if it functions similarly to and is intended for the same use as the predicate, and is composed of similar materials and design.

Acceptance Criteria (Implied by 510(k) Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Intended Use Equivalence: Device intended for the same use as legally marketed predicate devices.	Intended Use: "The intended use of LingLock is to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner." Predicate Comparison: "LingLock functions in a manner similar to and is intended for the same use as the Bondable Lingual Retainer currently manufactured by Ormco Corporation."
Technological Characteristics Equivalence: Device has similar technological characteristics (e.g., materials, design, mechanism of action) to legally marketed predicate devices.	Device Description: "The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide)..." Predicate Comparison: "...is composed of the same material and has the same bonding surface as the ceramic bracket manufactured by 3M Unitek." Mechanism: "When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner."
Performance Data: Any performance data (e.g., bench testing, biocompatibility) demonstrates equivalence or safety/effectiveness.	While not explicitly detailed as "acceptance criteria" and "reported performance" tables, the submission implies that all necessary testing for a Class II device (e.g., biocompatibility for the material, mechanical strength to function as a retainer) would have been performed and found acceptable to support the substantial equivalence claim, aligning with existing standards for similar devices. This document doesn't detail specific test results.

Study Information Overview:

Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This 510(k) submission does not describe a clinical study with a "test set" in the traditional sense of evaluating efficacy against a specific outcome. The submission relies on demonstrating substantial equivalence to predicate devices, implying that their performance is already accepted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No "ground truth" establishment using experts for a test set is described, as a clinical efficacy study was not presented.
Adjudication method for the test set:
- Not Applicable / Not Provided. No test set or adjudication method is described.
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:
- Not Applicable. The LingLock is a physical dental retainer, not an AI-assisted diagnostic or therapeutic device. This type of study is irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The LingLock is a physical dental retainer, not an algorithm, so standalone performance in this context is irrelevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth for an efficacy study is described. The "ground truth" for the device's market clearance is that it is substantially equivalent to predicate devices that are already deemed safe and effective for their intended use.
The sample size for the training set:
- Not Applicable / Not Provided. No "training set" is relevant or described for this type of physical medical device submission.
How the ground truth for the training set was established:
- Not Applicable / Not Provided. No training set is relevant or described.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.

K061042

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

JAN 1 9 2007

Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: April 2006

Device Name:

Trade Name LingLock .
Common Name Lingual Orthodontic Retainer .
Classification Name Retainer, Screw Expansion, Orthodontic, per 21 CFR § 872.5410 .

Devices for Which Substantial Equivalence is Claimed:

. Ormco Corporation, Bondable Lingual Retainer
3M Unitek, Clarity Ceramic Brackets .

Device Description:

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Intended Use of the Device:

The intended use of LingLock is to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.

Substantial Equivalence:

LingLock is substantially equivalent to other legally marketed devices in the United States. Linglock functions in a manner similar to and is intended for the same use as the Bondable Lingual Retainer currently manufactured by Ormco Corporation and is composed of the same material and has the same bonding surface as the ceramic bracket manufactured by 3M Unitek.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialist, Incorporated 100 Bayview Circle, Suite 6000 Newport Branch, California 92660-8915

JAN 1 9 2007

Rc: K061042

Trade/Device Name: LingLock Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: December 29, 2006 Received: January 4, 2007

Dear Ms. Boswell:

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. Boswell

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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,

Suen Kumno

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

Koblo 42 510(k) Number (if known):

Device Name: LingLock

Indications For Use:

Suer Uunm

1 CE SB XOL 4 Coquor, Dental De

K061042

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.