M-PM-DISC (PINK)

K140758 · Merz Dental GmbH · EBI · Sep 15, 2014 · Dental

Device Facts

• Record ID: K140758
• Device Name: M-PM-DISC (PINK)
• Applicant: Merz Dental GmbH
• Product Code: EBI · Dental
• Decision Date: Sep 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Merz Dental GmbH M-PM-Disc (Pink) is a device for fabrication of dental bases for removable dentures.

Device Story

M-PM-Disc (Pink) is a solid, highly cross-linked polymethylmethacrylate (PMMA) disc (branded OMP-N). Used by dental laboratories to fabricate removable denture bases via milling. Input is the solid PMMA disc; output is the milled, patient-specific denture base. Device benefits include material properties of PMMA suitable for dental prosthetics. Healthcare providers use the milled output to restore patient dentition.

Clinical Evidence

Bench testing only. Material (OMP-N) tested for physical/chemical properties per ISO 10477 and ISO 20795-1 (flexural strength, water sorption/solubility, fracture toughness). Biocompatibility testing performed per ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10.2 (guinea pig sensitization model), demonstrating non-toxic and non-sensitizing results.

Technological Characteristics

Solid disc of highly cross-linked PMMA (OMP-N). Dimensions: 90x15 mm to 114.8x25 mm. Composition: >95% PMMA, <2% residual MMA, plus colorants (TiO2, iron oxides, azocondensation pigment red, rayon fibers). Fabrication via milling. Standards: ISO 10477, ISO 20795-1, ISO 10993-5, ISO 10993-10.2.

Indications for Use

Indicated for the fabrication of dental bases for removable dentures.

Regulatory Classification

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.

Predicate Devices

• Promolux (K130076)
• M-PM-Disc (Tooth Colored) (K071548)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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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4. 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<br>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: | <a href="mailto:[e-mail]">[e-mail]</a> |
| 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)<br>For Casting of Denture Bases<br>K130076<br>Merz Dental GmbH<br>M-PM-Disc (Tooth Colored)<br>For Fabrication of Crowns and Bridges<br>K071548<br>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<br>(MPa) | 10477 | 93.4 |
| Water sorption<br>(ug/mm³) | 10477 | 26.5 |
| Water solubility<br>(ug/mm³) | 10477 | 0.2 |
| Flexural modulus<br>(MPa) | 20795-1 | 2678±74 |
| Flexural strength<br>(MPa) | 20795-1 | 90 ± 1.5 |
| Residual methyl methacrylate<br>(Mass % Fraction) | 20795-1 | 1.14 |
| Fracture Toughness (Kmax)<br>(MPa m^1/2) | 20795-1 | 1.41 +- 0.04 |
| Fracture work (Wf)<br>(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<br>(Tooth Colored) |
|-------------------------|--------------------------------------------|-----------------------------------------------------|-------------------------------------------------|
| Indications | Device for fabrication<br>of denture bases | Resin system for<br>fabrication of denture<br>bases | Device for fabrication of<br>crowns and bridges |
| Material<br>Composition | OMP-N PMMA | PMMA | OMP-N PMMA |
| Material Form | Solid Disc | Powder and Liquid | Solid Disc |
| Fabrication | Milling | Casting | Milling |
| Clearance | Subject of<br>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.