(220 days)
Not Found
No
The device description focuses on the chemical composition and curing methods of PMMA-based denture materials. There is no mention of AI, ML, or any computational processing.
No
Explanation: The device is a material used for preparing denture bases, not a therapeutic device that treats or prevents a disease.
No
The device is a material (resin) used for creating or repairing denture bases, which is a therapeutic rather than a diagnostic function. It does not analyze patient data or provide medical insights.
No
The device description clearly states the product is composed of PMMA resins and liquids, which are physical materials used to form denture bases. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for relining, repairing, or forming new denture bases. These are all procedures performed outside of the body on a dental prosthesis.
- Device Description: The device is a material (PMMA resin) used to construct or modify a dental prosthesis (denture). It is not designed to analyze a sample taken from the human body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the material itself, not on its ability to diagnose a condition.
- Predicate Devices: The predicate devices are also denture base materials, which are not typically classified as IVDs.
In summary, the Merz Dental GmbH Denture Base Resins are materials used in the fabrication and repair of dental prostheses, which are considered medical devices but not IVDs.
N/A
Intended Use / Indications for Use
The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:
- Relining a denture surface that contacts tissue ●
- Repairing a fractured denture, or
- Forming a new denture base
Product codes
EBI
Device Description
Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
• Promolux - A heat processed PMMA denture base resin
• Promolux Hi - A heat-processed PMMA denture base resin formulated for greater strength
· Weropress - A two part cold curing PMMA denture base resin
: PremEco PCS - A two part cold curing PMMA denture base resin with individual tints for aesthetic coloration of gingival portion of a denture base
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.
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
Tests of the cured polymer base materials was performed according to ISO 1567:2000 "Dentistry -Base polymers - Part 1: Denture base polymers" (for cold curing -- Type II: Class 1), and ISO 20795- (for hot curing-Type II, Class 2) The materials met the physical and residual methyl methacrylate monomer requirements.
These well known denture base materials were tested and found to comply with in vitro cytotoxicity (ISO 10993-5), guinea pig sensitization (ISO 10993-10.2), physical properties (ISO 1567:2000 for cold-curing polymers; and ISO 20795-1 for hot-curing polymers), and residual monomer requirements. These materials have a long history of safe use and have been extensively tested for physical and biological properties.
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
مسمسلمسلمسلسل
510(k) Summary
Merz Dental GmbH Denture Base Resins with Prosthetic Color System
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: | July 17, 2013 |
AUG 2 2 2013## Device Name
| Proprietary name: | Promolux, Promolux Hi, Weropress, PremEco PCS |
|---|---|
| Common name: | Denture Base Resin |
| Classification name: | Resin, Denture, Relining, Repairing, Rebasing |
| (21CFR 872.3760 Product Code EBI) | |
| Predicate Device: | Vertex hot-curing denture base material (K102654) |
| Vertex cold-curing denture base material (K102640) |
Device Description:
Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
| • Promolux | A heat processed PMMA denture base resin |
|---|---|
| • Promolux Hi | A heat-processed PMMA denture base resin formulated for |
| greater strength | |
| · Weropress | A two part cold curing PMMA denture base resin |
| : PremEco PCS | A two part cold curing PMMA denture base resin with |
| individual tints for aesthetic coloration of gingival portion of | |
| a denture base |
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System
1
is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.
Intended Use
The Merz Dental GmbH Denture Base Resins and Prosthetic Color System are for use in:
- · Relining a denture surface that contacts tissue
- · Repairing a fractured denture, or
- · Forming a new denture base
Technological characteristics and substantial equivalence
The technological characteristics of the Merz Dental GmbH Denture Base Resins with Prosthetic Color System, and those of the predicate devices, are shown in Tables 1 and 2.
The Merz Dental GmbH Denture Base Resins and the predicate devices are composed of the same acrylic material (PMMA), utilize the same curing methods (heat or cold cured), and have similar physical properties. They also have the same indications for use (fabrication of denture bases). They differ with regard to impact resistance (Promolux Hi has a higher impact resistance than the heat-cured predicate). The Merz Dental GmbH Prostheic Color System also adds flexibility in the technician's ability to vary the coloring of the gingival portion of the denture base.
2
Table 1: Comparison of Promolux and Promolux Hi to the Predicate Vertex Rapid Simplified
| Device | Vertex Rapid | Promolux | Promolux Hi |
|---|---|---|---|
| Heat-Cured | Simplified | ||
| Technology | PMMA Acrylic Plastic | PMMA Acrylic Plastic | PMMA Acrylic Plastic |
| Features | Heat curable | Heat curable | Heat curable |
| Materials | Two part mix of | Two part mix of | Two part mix of |
| polymethylmethacrylate | polymethylmethacrylate | polymethylmethacrylate | |
| powder and | powder and | powder and | |
| methacrylate monomer | methacrylate monomer | methacrylate monomer | |
| liquid | liquid | liquid | |
| Operations | Mixed into dough and | Mixed into dough and | Mixed into dough and |
| pressed into flask | pressed into flask | pressed into flask | |
| Indications | · Relining a denture | • Relining a denture | · Relining a denture |
| surface that contacts | surface that contacts | surface that contacts | |
| tissue | tissue | tissue | |
| · Repairing a fractured | · Repairing a fractured | · Repairing a fractured | |
| denture, or | denture, or | denture, or | |
| · Forming a new | · Forming a new | · Forming a new | |
| denture base | denture base | denture base | |
| Physical | Impact-resistance | Impact-resistance | Impact-resistance |
| Properties | Flexural strength | Flexural strength | Flexural strength |
| Flexural modulus | Flexural modulus | Flexural modulus | |
| Water sorption | Water sorption | Water sorption | |
| Solubility | Solubility | Solubility | |
| Bio- | Composed of | Composed of | Composed of |
| compatibility | biocompatible PMMA | biocompatible PMMA | biocompatible PMMA |
| with colorants. | with colorants. | with colorants. |
.
ﺘ
3
| Device Cold
| -Cured | Vertex Castavaria | Weropress | PremEco PCS |
|---|---|---|---|
| Technology | PMMA Acrylic plastic | PMMA Acrylic plastic | PMMA Acrylic plastic |
| Features | Cold Curing | PMMA Acrylic plastic | PMMA Acrylic plastic |
| Materials | Two part mix of | ||
| polymethylmethacrylate | |||
| powder and | |||
| methacrylate monomer | |||
| liquid | Two part mix of | ||
| polymethylmethacrylate | |||
| powder and | |||
| methacrylate monomer | |||
| liquid | Two part mix of | ||
| polymethylmethacrylate | |||
| powder and | |||
| methacrylate monomer | |||
| liquid | |||
| Operations | Mixed dough and | ||
| pressed into flask | Mixed dough and | ||
| pressed into flask | Mix powder and liquid | ||
| and brush on | |||
| Indications | • Relining a denture | ||
| surface that contacts | |||
| tissue | |||
| • Repairing a fractured | |||
| denture, | |||
| • Forming a new | |||
| denture base | • Relining a denture | ||
| surface that contacts | |||
| tissue | |||
| • Repairing a fractured | |||
| denture, | |||
| • Forming a new | |||
| denture base | • Relining a denture | ||
| surface that contacts | |||
| tissue | |||
| • Repairing a fractured | |||
| denture, | |||
| • Forming a new | |||
| denture base | |||
| Physical | |||
| Properties | Impact-resistance | ||
| Flexural strength | |||
| Flexural modulus | |||
| Water | |||
| Solubility | Impact-resistance | ||
| Flexural strength | |||
| Flexural modulus | |||
| Water | |||
| Solubility | Impact-resistance | ||
| Flexural strength | |||
| Flexural modulus | |||
| Water | |||
| Solubility | |||
| Bio- | |||
| compatibility | Composed of | ||
| biocompatible PMMA | |||
| with colorants. | Composed of | ||
| biocompatible PMMA | |||
| with colorants. | Composed of | ||
| biocompatible PMMA | |||
| with colorants. |
Table 2: Comparison of Weropress and PremEco PCS to Vertex Castavaria
Performance Testing
Tests of the cured polymer base materials was performed according to ISO 1567:2000 "Dentistry -Base polymers - Part 1: Denture base polymers" (for cold curing -- Type II: Class 1), and ISO 20795- (for hot curing-Type II, Class 2) The materials met the physical and residual methyl methacrylate monomer requirements.
These well known denture base materials were tested and found to comply with in vitro cytotoxicity (ISO 10993-5), guinea pig sensitization (ISO 10993-10.2), physical properties (ISO 1567:2000 for cold-curing polymers; and ISO 20795-1 for hot-curing polymers), and residual monomer requirements. These materials have a long history of safe use and have been extensively tested for physical and biological properties.
4
Conclusions:
Merz Dental GmbH denture base resins (Promolux Hi, Weropress and PremEco PCS) have similar technological and performance characteristics as the currently marketed predicate denture base resins (Vertex Rapid Simplified and Vertex Castavaria). The products are composed of the same biocompatible acrylic plastic (PMMA), utilize the same preparation and casting techniques, and have identical indications for use. Their physical properties are similar for each type of curing system (hot or cold) with the exception that the hot-curing Merz Dental Promolux Hi has a higher impact resistance than the hot-curing Vertex Rapid Simplified. In addition, the Merz Dental PremEco PCS product allows greater flexibility in the coloring of the gingival portion of the denture than the predicate device. Based on the above similarities and differences, it is concluded that the Merz Dental GmbH denture base resin products (Promolux, Promolux Hi, Weropress and PremEco PCS) are substantially equivalent to the predicate denture base resin products (Vertex Rapid Simplified and Vertex Castavaria).
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Merz Dental GmbH C/O Richard G. Hunter, M.S., RAC Principal Washington Regulatory Consultants 5616 Mariola Place NE ALBUQUERQUE, New Mexico 87111
Re: K130076
Trade/Device Name: Merz Denture Base Resins with Prosthetic Color System Regulation Number: 21 CFR 872.3760 Regulation Name: Resin Denture. Relining, Repairing, Rebasing Regulatory Class: II Product Code: EBI Dated: July 17, 2013 Received: July 18, 2013
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). and Oosmetie for (110) the device. subject to the general controls provisions of the Act. The r ou may, therefore, many of the Act include requirements for annual registration, listing of general controls proficioning 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 n your device is elaboriise (boo assns). Existing major regulations affecting your device can be may be subject to additions. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address hup://www.fda.gov/MedicalDevices/Resources/orYou/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/ReportalProblem/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 Tou may of Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours.
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known): ¥13007 ص
Device Name: Merz Denture Base Resins with Prosthetic Color System
Indications for Use:
The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:
- Relining a denture surface that contacts tissue ●
- Repairing a fractured denture, or
- Forming a new denture base
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)
Andrew I. Steen -S. پياز -2013.08.21 11:08:54 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
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510(k) Number:_K | 30076