LAR Manufacturing, LLC Ceramic Brackets are available if the following prescriptions: Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are produced using Al2O3, translucent polycrystalline aluminum oxide (99.9%). These Ceramic Brackets are bonded to the teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.

AI/ML Overview

This 510(k) premarket notification is for orthodontic ceramic brackets and does not describe software or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI performance.

The submission focuses on demonstrating "substantial equivalence" to a predicate device (Mystic Orthodontic Ceramic Brackets, K042178), primarily through material composition and intended use.

Here's why the requested information cannot be extracted from this document:

No AI/Software Component: The device is a physical, non-digital orthodontic bracket. The concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), training/test sets, ground truth, or multi-reader studies are not applicable.
Substantial Equivalence Pathway: 510(k) submissions, especially for devices like this, typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (materials, dimensions, manufacturing processes) and intended use, rather than conducting new clinical performance studies that would generate the kind of data you're asking for.

If this were a 510(k) for a medical device software with an AI component, the document would contain sections detailing performance metrics, validation studies, and possibly human-in-the-loop evaluations. This particular document however, does not.

Summary

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K052245

LAR Manufacturing, LLC
Orthodontic Ceramic Brackets	SEP 23 2005

510(k)Summary	This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R.$ 807.92.
SubmissionCorrespondant:Phone:Fax:Contact:e-mail:	Emergo Group Inc.2454 McMullen Booth Road, Suite 427Clearwater, FL 33759 USA727-797-4727727-797-4757lan GordonSenior Vice Presidentigordon@emergogroup.com
SubmissionSponsor:	LAR Manufacturing, LLC6828 Commerce Ave.Port Ritchey, FL 34668
Date Prepared	August 5, 2005
Name of device	Orthodontic Ceramic Brackets - Accent Series and ExceedSeries Ceramic Brackets
ClassificationNames	Bracket, Ceramic, Orthodontic
DeviceClassification	Regulatory Class: IIProduct Code: NJMClassification Panel: DentalRegulation Number: 21 C.F.R. 872.5470

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510(k) Summary of Safety and Effectiveness

LAR Manufacturing, LLC Orthodontic Ceramic Brackets

PredicateDevice(s)
510(k)#	Device	Manufacturer
K042178	Mystic OrthodonticCeramic Brackets	Dentsply International
DeviceDescription	LAR Manufacturing, LLC Ceramic Brackets are available ifthe following prescriptions:Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets areproduced using Al2O3, translucent polycrystalline aluminumoxide (99.9%). These Ceramic Brackets are bonded to theteeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.
Indications	LAR Manufacturing, LLC Orthodontic Ceramic Brackets areindicated for orthodontic movement of teeth.
TechnologicalCharacteristics	The function and performance of the LAR Manufacturing,LLC Orthodontic Ceramic Brackets are identical to thepredicate device listed above. There is no difference infundamental scientific technology. The LAR Manufacturing,LLC Orthodontic Ceramic Brackets are made of the samematerial as the predicate device currently on the market andhas the same overall intended use.
Conclusion	By definition, a device is substantially equivalent when thedevice has the same intended use and the sametechnological characteristics as the predicate device.There are no major differences between the LARManufacturing, LLC and the predicate device cited, andtherefore the LAR Manufacturing, LLC Orthodontic CeramicBrackets do not raise any questions regarding safety andeffectiveness.The LAR Manufacturing, LLC Orthodontic Ceramic Bracketsas designed, are as safe and effective as the predicatedevice, and the device is determined to be substantiallyequivalent to the referenced predicate device currently onthe market.

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510(k) Summary of Safety and Effectiveness

LAR Manufacturing, LLC Orthodontic Ceramic Brackets

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 of three horizontal lines that curve and converge, resembling a stylized human figure.

Public Health Service

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LAR Manufacturing, LLC C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759

Re: K052245

Trade/Device Name: Accent Series™ Ceramic Brackets and Exceed Series™ Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 12, 2005 Received: August 17, 2005

Dear Mr. Gordon:

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. Ian P. Gordon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dry o loualies of our device complies with other requirements of the Act or that FDA has made a decemination and Jaistered by other Federal agencies. You must comply with all reteral statures and regulations animals in the registration and listing (21 CFR Part 807); all the Act s requirements; morading; butacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), E00 mixt 820); and if applicable, the electronic product radiation Systems (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) This letter witi anow you to oegin manetal equivalence of your device of your device to a legally premarked notheation: "The PDF Intently of our 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 If you desire specific darroliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities 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 vours,

Chiu S. Lin, PhD

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): K052245

Orthodontic Ceramic Brackets Device Name:

Indications for Use:

The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

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

Kein Muley

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

Page 1 of 1

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.