(173 days)
Not Found
No
The description focuses on the material composition and physical properties of a PMMA disc for fabricating dental bases, with no mention of AI or ML.
No
The device is a material (PMMA disc) for fabricating dental bases. It does not directly treat or diagnose a disease or condition. The performance studies focus on material properties and biocompatibility, not therapeutic efficacy.
No
This device is a material for fabricating dental bases. It does not perform any diagnostic function.
No
The device is a physical disc made of PMMA, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Device for fabrication of dental bases for removable dentures." This describes a material used in the creation of a medical device (a denture), not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is a solid disc of PMMA material. This is a manufacturing material, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Reagents or assay components
The device is a material used in a dental laboratory setting to create a physical component of a denture. This falls under the category of a medical device used for fabrication, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Device for fabrication of dental bases for removable dentures.
Product codes
EBI, EBG
Device Description
The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.
The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Merz Dental GmbH c/o Richard G. Hunter, MS Regulatory Affairs Consultant Washington Regulatory Consultants 5616 Mariola PL NE Albuquerque, NM 87111
Re: K140758
Trade/Device Name: M-PM-Disc (Pink) Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Codes: EBI, EBG Dated: August 5, 2014 Received: August 12, 2014
Dear Mr. Hunter:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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- Indications for Use
510(k) Number (if known):
Device Name: M-PM-Disc (Pink)
Indications for Use:
.
Device for fabrication of dental bases for removable dentures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Summary
Merz Dental GmbH M-PM-Disc (Pink)
Submitter
| Company Name: | Merz Dental GmbH |
|---|---|
| Address: | Eetzweg 20 |
| Lutjenburg, Germany D-24321 | |
| Contact Name: | Dr. Med. Claudia Bobrowski |
| Telephone No. | (011) 43 81/4 03-4 11 |
| Fax No. | (011) 43 81/4 09-1 07 |
| e-mail: | Claudia.bobrowski@merz-dental.de |
| Date of Summary: | August 5, 2014 |
| Device Name | |
| Proprietary name: | M-PM-Disc (Pink) |
| Common name: | Denture Base |
| Classification name: | Resin, Denture, Relining, Repairing, Rebasing |
| Predicate Devices: | Denture Resins ((e.g. Promolux) |
| For Casting of Denture Bases | |
| K130076 | |
| Merz Dental GmbH | |
| M-PM-Disc (Tooth Colored) | |
| For Fabrication of Crowns and Bridges | |
| K071548 | |
| Merz Dental GmbH |
.
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Intended Use
Merz Dental GmbH M-PM-Disc (Pink) is a device for fabrication of dental bases for removable dentures.
Device Description
The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.
The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.
Technological Characteristics
The Merz Dental GmbH OMP-N PMMA has been tested according to the following standards. The results are presented in the table below.
| Physical Parameter* | Standard (ISO) | OMP-N |
|---|---|---|
| Flexural strength | ||
| (MPa) | 10477 | 93.4 |
| Water sorption | ||
| (ug/mm³) | 10477 | 26.5 |
| Water solubility | ||
| (ug/mm³) | 10477 | 0.2 |
| Flexural modulus | ||
| (MPa) | 20795-1 | 2678±74 |
| Flexural strength | ||
| (MPa) | 20795-1 | 90 ± 1.5 |
| Residual methyl methacrylate | ||
| (Mass % Fraction) | 20795-1 | 1.14 |
| Fracture Toughness (Kmax) | ||
| (MPa m^1/2) | 20795-1 | 1.41 +- 0.04 |
| Fracture work (Wf) | ||
| (J/m2) | 20795-1 | 202 +- 13 |
Substantial Equivalence
M-PM-Disc (Pink) is substantially equivalent to predicate denture base resin systems, such as the Merz Dental GmbH Denture Base Resins one of which is the hot-curing Promolux and
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Merz Dental GmbH M-PM Disc (Tooth Colored) for fabrication of crowns and bridges. The three devices are compared in the table below.
| Device | M-PM-Disc (Pink) | Promolux (Pink) | M-PM-Disc
(Tooth Colored) |
|-------------------------|--------------------------------------------|-----------------------------------------------------|-------------------------------------------------|
| Indications | Device for fabrication
of denture bases | Resin system for
fabrication of denture
bases | Device for fabrication of
crowns and bridges |
| Material
Composition | OMP-N PMMA | PMMA | OMP-N PMMA |
| Material Form | Solid Disc | Powder and Liquid | Solid Disc |
| Fabrication | Milling | Casting | Milling |
| Clearance | Subject of
Application | K130076 | K071548 |
| Manufacturer | Merz Dental, GmbH | Merz Dental, GmbH | Merz Dental, GmbH |
As shown in the table, both the M-PM-Disc (Pink) and Promolux are composed of polymethylmethacrylate (PMMA) with pink colorants, and are indicated for the fabrication of dental bases. In addition the M-PM-Disc (Pink) has the identical material composition, method of manufacture, and final fabrication method as the Merz Dental GmbH M-PM-Disc (Tooth Colored), a device for fabrication of crowns and bridges. Both M-PM-Disc (Pink) and M-PM-Disc (Tooth Colored) are solid PMMA discs composed of highly cross-linked PMMA (OMP-N), and milled at the dental lab into the final shape of the prosthesis.
Merz Dental has tested OMP-N for physical/chemical properties and biocompatibility. The PMMA material met the applicable standards for physical/chemical properties (ISO 10477 and 20795-1), and was nontoxic and non-sensitizing in the in vitro cytotoxicity test system (ISO 10993-5) and the guinea pig sensitization model (ISO 10993-10.2).
Summary
Merz Dental GmbH M-PM-Disc (Pink) has similar indications, composition, manufacturing methods and biocompatibility as the predicate devices. Therefore Merz Dental considers the M-PM-Disc (Pink) to substantially equivalent to the predicate devices.