. Luting of abutments to dentures (LuxaCore)
. Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
. Repair material for provisionals
. Bite registration material.
. Build up material for plastic bite rails (occlusal individualisation).
. Cement for pins and posts
. Semipermanent restorative material (e.g., in childrens' teeth)

Device Description

LuxaCore: LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material.

LuxaCore Dual: LuxaCore Dual is a dual cure (chemical and/or light cure), radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material

AI/ML Overview

The provided text is a 510(k) Premarket Notification for dental materials (LuxaCore / LuxaCore Dual) and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of an AI/medical imaging device.

Specifically, the document:

Describes dental core build-up and restorative materials.
Identifies predicate devices for substantial equivalence.
Lists indications for use for the dental materials.
States it's an Abbreviated 510(k) and references conformity with FDA guidance for "Dental Composites - Premarket Notification."
Concludes the materials are "safe and effective for their intended use" based on technological characteristics and comparison to predicate devices.
Includes correspondence from the FDA confirming substantial equivalence.

There is no mention of:

Acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for an AI device.
Any study that tests an AI algorithm's performance against such criteria.
Sample sizes for test or training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or types of ground truth relevant to AI performance evaluation.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI device meets them based on the provided text.

Summary

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DMG USA Inc. Abbreviated 510(k) Premarket Notification

July 6, 2001 LuxaCore / LuxaCore Dual

K012307

AUG 2 3 2001

510(k) Summary

Trade Name:	LuxaCore / LuxaCore Dual
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901
	Registration # not yet assigned
Device Generic Name:	Dental core build-up and restorative material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Predicate Devices:	Centrix Encore (Alpha-Dent); K932826Core Paste (Den-Mat); K872510Bisfil 2B (BISCO); K964000LuxaCore (Zenith); K982201

Product Description:

LuxaCore:

LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material.

LuxaCore Dual:

LuxaCore Dual is a dual cure (chemical and/or light cure), radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material

Indications for Use:

The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts.

LuxaCore and LuxaCore Dual can also be used for:

. Luting of abutments to dentures (LuxaCore)
. Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
. Repair material for provisionals
. Bite registration material.
. Build up material for plastic bite rails (occlusal individualisation).
. Cement for pins and posts
. Semipermanent restorative material (e.g., in childrens' teeth)

Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG USA, Inc. has provided information to demonstrate

000048

{1}------------------------------------------------

conformity with FDA's guidance document entitled Dental Composites - Premarket Notification, Comerinaty water Dr. I D July - Dentistry - Polymer-based filling, restorative and luting materials.

Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the LuxaCore / LuxaCore Dual materials have been shown to be safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DMG USA, Incorporated C/O Ms. Pamela Papineau Requlatory Affairs Specialist Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K012307 Trade/Device Name: Luxacore/Luxacore Dual Requlation Number: 872.3690 Regulatory Class: II Product Code: EBF Dated: July 6, 2001 Received: July 23, 2001

Dear Ms. Papineau:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory

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Page 2 - Ms. Papineau

In addition, FDA may publish further announcements action. aceres in the Federal Register. Register. Please note: this response to your premarket notification submission does Unis response to your premaince necessor based one 531 through 542 of the Act for devices under the Electronic chrough 312 or on the motions, 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 markets proceed proceed 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Olin S-Foton

Timothy A. Ulatows 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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DMG USA Inc. Abbreviated 510(k) Premarket Notification

July 6, 2001

LuxaCore / LuxaCore Dual

K012307

Page -1 of ー

510(k) Number (if known): _

Device Name: LuxaCore / LuxaCore Dual

Indications for Use:

The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts.

LuxaCore and LuxaCore Dual can also be used for:

Splinting of teeth in combination with wires, Kevlar or Ribbond-type . materials
Repair material for provisionals ●
Bite registration material. .
Build up material for plastic bite rails (occlusal individualisation). ●
Cement for pins and posts .
Semipermanent restorative material (e.g., in childrens' teeth) .

LuxaCore can be used for luting of abutments to dentures.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the -Counter Use

M.Eldridge to MSR

ivision of Dental, Infection Control, ୂର୍ଣ General Hospital Devic 13 : O(k) Number

000099

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.