(164 days)
Not Found
No
The summary describes a PMMA blank for milling splints and performance testing related to material properties, not AI/ML capabilities.
Yes
The device is described as "Ceramill A-Splint is indicated for the fabrication of removable bite splints." A bite splint is a therapeutic device used to treat various dental conditions.
No
The device is described as a material (PMMA blanks) used for fabricating removable bite splints, not for diagnosing conditions. Its performance studies focus on material properties and durability.
No
The device description explicitly states that Ceramill A-Splint are "ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints." This indicates a physical material (PMMA blanks) used in a manufacturing process, not a software-only device.
Based on the provided information, 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. This is a dental device used in the mouth for mechanical purposes (preventing teeth grinding, etc.).
- Device Description: The device is a material (PMMA blanks) used for milling these dental splints.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., to detect diseases, conditions, or measure substances.
The information provided clearly describes a dental material used for creating a physical dental appliance, not a diagnostic test.
N/A
Intended Use / Indications for Use
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
Product codes (comma separated list FDA assigned to the subject device)
MQC
Device Description
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
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)
To demonstrate safety and effectiveness of Ceramill A-Splint and to show substantial equivalence to the predicate device, Amann Girrbach AG completed the following non-clinical tests.
The Ceramill A-Splint passed the testing in accordance with internal requirements, national standards, and international standards shown below:
- Biocompatibility assessment was conducted according to ISO 10993-1. Considering the chemically defined composition, the existing dental history with PMMA polymers and the inert material properties substantiated by highly sensitive chemical analysis, it was determined that no other biocompatibility testing than cytotoxicity testing was required. No cytotoxic effects were observed in presence of the test material extracts.
- Bench performance testing conducted in conformity with ISO 20795-2:2013 met all of the requirements set forth in the standard for residual monomer testing, 3-point bending strength, water solubility, water absorption, flexural modulus, fracture toughness, polishability, and porosity.
- Wearing testing based on an adapted Ivoclar method in a chewing simulator – the wearing period has been determined to be of a maximum of three years.
- Shelf Life Testing – it was demonstrated that key characteristics do not degrade after four years of storage.
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name is in a sans-serif font.
December 20, 2019
Amann Girrbach AG % Rachel Paul Senior Consultant QA & RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP N1
Re: K191836
Trade/Device Name: Ceramill A-Splint Regulatory Class: Unclassified Product Code: MQC Dated: October 28, 2019 Received: October 31, 2019
Dear Rachel Paul:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191836
Device Name
Ceramill A-Splint
Indications for Use (Describe)
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
Type of Use (Select one or both, as applicable)
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------- |
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3
510(k) K191836 Summary
Ceramill A-Splint
1. Submission Sponsor
Amann Girrbach AG
Herrschaftswiesen 1
6842 Koblach
AUSTRIA
Contact: Debora Engel
Title: Regulatory Affairs Manager
Email: Debora.engel@amanngirrbach.com
Office number: + 49 (7231) 957-260
2. Submission Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague, 2514 AP
THE NETHERLANDS
Office Phone: +31 (0) 70 345 8570 / Direct: +31 (0) 70 850 8249
Contact: Rachel Paul
Title: Senior Consultant, QA & RA
Email: LST.AUS.ProjectManagement@ul.com
Cell Phone : 00 6 89 83 16 09
- Date Prepared
28 October 2019
-
- Device Identification
4
Trade/Proprietary Name: Ceramill A-Splint Common/Usual Name: Occlusal splints Classification Name: Mouthguard, Prescription N/A - Unclassified Regulation Number: Product Code: MQC Device Class: N/A - Unclassified Classification Panel: Dental
5. Legally Marketed Predicate Device
K134015, M-PM-Disc (Clear), Merz Dental GmbH
6. Indication for Use Statement
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
7. Device Description
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
8. Comparison of Technology
The following table compares the Ceramill A-Splint to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. There are no differences in technology.
| Attribute | Ceramill A-Splint | M-PM-Disc | Comparison |
|---|---|---|---|
| Manufacturer | Amann Girrbach AG | Merz Dental GmbH | N/A |
| 510(k) Number | To be determined (TBD) | K134015 | N/A |
| Product Code | MQC | MQC | Same |
| Regulation | |||
| Reference | Unclassified | Unclassified | Same |
| Indications for Use | Ceramill A-Splint is | ||
| indicated for the | The Merz Dental GmbH | ||
| M-PM-Disc (Clear) is | |||
| indicated for the | Similar; both devices are | ||
| indicated for the | |||
| production of removable | |||
| Attribute | Ceramill A-Splint | M-PM-Disc | Comparison |
| fabrication of removable | |||
| bite splints. | fabrication of removable | ||
| bite splints such as | |||
| mouthguards and | |||
| nightguards. | bite splints. The | ||
| indications for use of | |||
| Ceramill A-Splint fall | |||
| within the intended use of | |||
| unclassified mouthguard | |||
| devices. Both devices are | |||
| for prescription only. | |||
| Material | Solid | ||
| Polymethylmethacrylate | |||
| (PMMA) | |||
| No pigments | Solid | ||
| Polymethylmethacrylate | |||
| (PMMA) | |||
| No pigments | Same | ||
| Residual monomer | Less than 1% residual | ||
| monomer | Less than 1% residual | ||
| monomer | Same; both devices meet | ||
| requirements from ISO | |||
| 20795-2:2013 (100 MPa | 91.5 MPa - 96.6 MPa | Similar; the specifications | |
| are in the same range. | |||
| This minor variance does | |||
| not introduce additional | |||
| safety or efficacy | |||
| concerns. Both devices | |||
| meet requirements from | |||
| ISO 20795-2:20131 (≥50). | |||
| Water solubility |