(102 days)
Not Found
No
The device description and intended uses are for a physical dental material used as a matrix or bite registration material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "functional therapeutic cases as e.g. a Lucia Jig, anterior repositioning splint etc." This indicates its use in therapeutic applications.
No
The device is a material used as a matrix, for bite registration, and in the fabrication of various dental appliances. Its listed uses involve creating or aiding in the creation of dental forms and records, not in diagnosing disease or conditions.
No
The device description and intended uses clearly indicate that LuxaForm Plus is a physical material (a quick pre-impression matrix and bite registration material) used in dental procedures, not a software application.
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 or in the patient's mouth, or on dental models derived from the patient. These are not tests performed on samples taken from the body to diagnose a condition.
- Device Description: The description confirms its use as a "pre-impression matrix" and "bite registration material," both of which are used in direct patient care or model fabrication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
LuxaForm Plus is indicated for the following uses:
- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- . Articulation of diagnostic molds
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models ●
- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
The LuxaForm Plus is a detailed quick pre-impression matrix used in the fabrication of provisional crowns and bridges and can also be used as a bite registration material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental / mouth
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)
Substantial equivalence for this device was based on similarities in design, chemical composition and performance specifications as compared to predicate materials. The materials, performance specifications and essential design characteristics of the LuxaForm Plus are identical to those of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
JAN 1 6 2004
510(k) Summary
LuxaForm Plus Trade Name:
Sponsor: DMG USA, Inc. 414 South State Street Dover, DE 19901 Registration # not yet assigned Owner/Operator #9005969
Device Generic Name:
Temporary Crown and Bridge Resin Material
Classification:
According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Devices:
The proposed LuxaForm Plus is substantially equivalent to the currently marketed DMG USA LuxaForm material, which was cleared for marketing bv FDA in K000951. In addition, the chemical composition of the LuxaForm Plus material includes materials found in both the Advantage Dental Products Temporary Crown Matrix Buttons as cleared in K900389 and the Heraeus Kulzer Paladur dental resin material, which was cleared in K915898.
Product Description:
The LuxaForm Plus is a detailed quick pre-impression matrix used in the fabrication of provisional crowns and bridges and can also be used as a bite registration material.
Indications for Use:
LuxaForm Plus is indicated for several uses:
- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- Articulation of diagnostic molds .
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models .
Confidential - This file contains proprietary, trade secret information which is the property of DMG USA and DMG Hamburg. This information may only be disclosed to or viewed by authorized (in writing) representatives of DMG, Delphi Medical Device Consulting, and the U.S. Food and Drug Administration.
1
- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .
Safety and Performance:
Substantial equivalence for this device was based on similarities in design, chemical composition and performance specifications as compared to predicate materials. The materials, performance specifications and essential design characteristics of the LuxaForm Plus are identical to those of the predicate devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the LuxaForm Plus has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
DMG USA, Incorporated C/O Ms. Pamela Papineau, RAC Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K033227
Trade/Device Name: Luxaform Plus Regulation Number: 872-3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 31, 2003 Received: January 7, 2004
Dear Ms. Papineau:
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.
3
Page 2 - Ms. Papineau
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics 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/dsma/dsmamain.html
Sincerely yours,
Chih-Lin, Ph.D.
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
4
Page
510(k) Number (if known):
Device Name: LuxaForm Plus____________________________________________________________________________________________________________________________________________________
Indications for Use:
LuxaForm Plus is indicated for the following uses:
- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- . Articulation of diagnostic molds
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models ●
- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospita | |
| Infection Control, Dental Devices | |
| 510(k) Number: |
| Prescription Use ✓ (Per 21 CFR 801.109) | OR Over-the -Counter Use |
|---|---|
| ----------------------------------------- | -------------------------- |
| (Division Sign-Off) | Susan Runser |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K033227 |
Confidential - This file contains proprietary, trade secret information which is the property of DMG USA and DMG Hamburg. This information may only be disclosed to or viewed by authorized (in writing) representatives of DMG, Delphi Medical Device Consulting, and the U.S. Food and Drug Administration.