(105 days)
Not Found
No
The device description and performance studies focus solely on the material composition and physical properties of a PMMA disc used for milling bite splints. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device itself is a material (disc) for fabricating bite splints, not the therapeutic device (bite splint) itself. The therapeutic aspect comes from the fabricated bite splint.
No
The device is described as a material for fabricating removable bite splints, not for diagnosing medical conditions.
No
The device description clearly states it is a solid disc composed of PMMA, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of removable bite splints (mouthguards and nightguards). These are devices used in the mouth for a therapeutic purpose (protecting teeth, managing bruxism, etc.).
- Device Description: The device is a solid disc of PMMA material used to create the bite splints.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a material used in the manufacturing of a medical device.
Therefore, based on the provided information, the Merz Dental GmbH M-PM-Disc (Clear) is a material used to fabricate a medical device, but it is not an In Vitro Diagnostic device itself.
N/A
Intended Use / Indications for Use
The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.
Product codes (comma separated list FDA assigned to the subject device)
MQC
Device Description
The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.
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)
The M-PM-Disc (Clear) has not been tested clinically.
Both the M-PM-Disc (Clear) and the predicate devices are fabricated from PMMA. The PMMA used in M-PM-Disc (Clear) has been tested for biocompatibility and physical properties according ISO 10993-1 tissue contacting requirements. The testing was performed on a virtually identical PMMA--Merz Dental artegral plastic teeth, since the latter material is identical to that of M-PM-Disc (Clear) but has added tooth-color pigments. The material met the biocompatibility requirements of ISO 10993-1--in particular the material was non-cytotoxic, non-irritating and non-sensitizing. The M-PM-Disc (Clear) material, as represented by the PMMA (tooth colored) in Merz Dental artegral plastic teeth, also meets the requirements of ISO 3336:1996, Dentistry-Synthetic, Polymer Teeth).
The tests discussed above and in the non-clinical testing section indicate that the subject device is safe and effective for its intended use and performs as well or better than predicate device(s).
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.
K062828 -- Mouthguard and Aligner Materials, DENTSPLY Intl., K030588 -- artegral Denture Teeth, Merz Dental GmbH, K071548 -- M-PM-Disc (Tooth Colored), Merz Dental, GmbH
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
N/A
0
K134.015
APR 1 1 2014
510(k) Summary
Merz Dental GmbH M-PM-Disc (Clear)
| Submitter: | Merz Dental GmbH
Eetzweg 20
Lutjenburg, Germany D-24321 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Richard G. Hunter, MS, RAC
505.400.4992; wrchunter@comcast.net |
| Date of Summary: | April 8, 2014 |
| Trade Name: | M-PM-Disc (Clear) |
| Regulation Name: | Mouthguard |
| Regulation Class: | Not Classified |
| Product Code: | MQC |
| Predicate Devices: | K062828 -- Mouthguard and Aligner Materials, DENTSPLY Intl.
K030588 -- artegral Denture Teeth, Merz Dental GmbH
K071548 -- M-PM-Disc (Tooth Colored), Merz Dental, GmbH |
Device Description:
The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.
Intended Use
The Mertz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguards and nightguards.
1
Technological characteristics and substantial equivalence
The MP-M-Disc (Clear ) has the same indications for use and configurations as the predicate devices. It also has the same composition (acrylic polymers) which meet the ISO requirements for physical properties and biocompatibility for these dental indications. The M-PM-Disc (Clear) and the predicate device differ in their method of fabrication. M-PM-Disc (Clear) is milled from solid PMMA whereas the predicate device (Mouthguard and Aligner Material, K062828) is thermoformed. Side-by-side comparisons of the properties of the M-PM-Disc (Clear) bite splint to the predicate is presented below in Table 1. Based on these comparisons, the MP-M-Disc (Clear) is not significantly different, and thus substantially equivalent, to the predicate devices.
| | M-PM-Disc (Clear) | Mouthguard and
Aligner Materials
K062828 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use | Bite Splint/Mouthguard | Same |
| Composition | Acrylic Polymer (PMMA) Solid | Same |
| Colorants | None | Same |
| Fabrication Method | Milling | Thermoforming |
| Physical Properties | Meets applicable ISO Standard
Tested to ISO 1567:
Flexural Strength Limit: >65 MPa
Flexural Modulus: >2000 MPa
Water Absorption: