(31 days)
None
No
The document describes a dental core build-up material and its intended uses, with no mention of AI or ML technology.
No.
The intended uses listed for LuxaCore and LuxaCore Dual, such as core material, luting, splinting, repair, bite registration, build-up, cement, and semipermanent restorative material, describe a dental material used for structural and restorative purposes, not for treating or rehabilitating a disease, injury, or disability.
No
The device is described as a core build-up material and is used for restorative and structural purposes in dentistry, not for diagnosing conditions.
No
The device description clearly states it is a "chemical-curing, radiopaque two-component core build-up material" and a "dual cure (chemical and/or light cure), radiopaque two-component core build-up material," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient (core build-up, luting, splinting, repair, bite registration, etc.). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a material used for dental restoration and build-up, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, LuxaCore and LuxaCore Dual are dental materials used for restorative and reconstructive procedures, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
EBF
Device Description
LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932826, K872510, K964000, K982201
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DMG USA Inc. Abbreviated 510(k) Premarket Notification
July 6, 2001 LuxaCore / LuxaCore Dual
AUG 2 3 2001
510(k) Summary
| Trade Name: | LuxaCore / LuxaCore Dual |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, 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, and |
| Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | Centrix Encore (Alpha-Dent); K932826 |
| Core Paste (Den-Mat); K872510 | |
| Bisfil 2B (BISCO); K964000 | |
| LuxaCore (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.
2
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
3
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
4
DMG USA Inc. Abbreviated 510(k) Premarket Notification
July 6, 2001
LuxaCore / LuxaCore Dual
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)
OR
Over-the -Counter Use
M.Eldridge to MSR
ivision of Dental, Infection Control, ୂର୍ଣ General Hospital Devic 13 : O(k) Number
000099