(87 days)
Not Found
No
The device description and performance studies focus on the material properties and manufacturing process of PMMA blanks for CAD/CAM milling, with no mention of AI or ML.
No.
The device is a material for creating temporary dental restorations, not a therapeutic device that treats or prevents a disease.
No.
The device is a temporary restorative material (PMMA blanks) used for crowns and bridges, and for verifying fit. It does not perform any diagnosis of a medical condition.
No
The device description clearly states that Ceramill A-Temp are "ready to use, polymethyl methacrylate (PMMA) based computer-aided manufacturing (CADCAM) blanks". This indicates the device is 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Ceramill A-Temp is a material used for milling temporary dental crowns and bridges and for verifying fit. It is a physical material used in the mouth or on a model of the mouth, not a test performed on a biological sample outside the body.
- Intended Use: The intended uses are related to creating temporary dental restorations and verifying their fit, which are mechanical and structural functions, not diagnostic testing.
- Device Description: The description focuses on the material composition (PMMA) and form (blanks for milling), not on reagents, assays, or analytical processes typical of IVDs.
- Performance Studies: The performance studies listed are related to the material's physical properties, biocompatibility, and durability, which are relevant for a dental material, not for the analytical performance of a diagnostic test.
Therefore, Ceramill A-Temp falls under the category of a dental material or device used for restorative purposes, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
- Temporary anterior and posterior crowns with a wearing time of maximum three years
- Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
- Verifying the fit on the plaster model/mouth before the final restoration
Product codes
EBG, POW
Device Description
Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.
Ceramill A-Temp is available as a disk (round form) or as an arch-form (or “U”-shape) disk or as block shape blanks.
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
To demonstrate safety and effectiveness of Ceramill A-Temp and to show substantial equivalence to the predicate device, Amann Girrbach AG completed of the following non-clinical tests. The Ceramill A-Temp meets all the requirements for overall design and biocompatibility confirming that the design output meets the design inputs and specifications for the device.
The Ceramill A-Temp passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and its substantial equivalence to the subject device:
- Biocompatibility testing per ISO 10993-1. No cytotoxic effects were observed in presence of the test material extracts. There was no indication that any ingredients/residues of the blank material are released in toxicologically relevant concentrations during the intended dental use.
- Residual monomer testing – Ceramill A-Temp met requirement from ISO 10477:2018.
- 3-point bending strength – Ceramill A-Temp met requirement from ISO 10477:2018.
- Water solubility - Ceramill A-Temp met requirement from ISO 10477:2018.
- Water absorption – Ceramill A-Temp met requirement from ISO 10477:2018.
- Polishability - Ceramill A-Temp met requirement from ISO 10477:2018.
- Wearing period – 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2019
Amann Girrbach AG % Rachel Paul Senior Consultant QA/RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP NETHERLANDS
Re: K191843
Trade/Device Name: Ceramill A-Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: July 8, 2019 Received: July 9, 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.
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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) 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 medical devices and radiation-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.
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191843
Device Name Ceramill A-Temp
Indications for Use (Describe)
-
Temporary anterior and posterior crowns with a wearing time of maximum three years
-
Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
-
Verifying the fit on the plaster model/mouth before the final restoration
| 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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K191843 510(k) Summary
Ceramill A-Temp
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
3. Date Prepared
08 July 2019
4. Device Identification
Trade/Proprietary Name: Ceramill A-Temp
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Common/Usual Name: PMMA CAD/CAM Temporary crown and bridge blanks Classification Name: Temporary crown and bridge resin Regulation Number: 872.3770 Product Code: EBG Device Class: 11 Classification Panel: Dental
5. Legally Marketed Predicate Device
K112967, PMMA CAD/CAM Disc, Polident d.o.o. Dental Products Industry
6. Indication for Use Statement
Temporary anterior and posterior crowns with a wearing time of maximum three years.
Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years.
Verifying the fit on the plaster model/mouth before the final restoration.
7. Device Description
Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.
Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.
8. Substantial Equivalence Discussion
The following table compares the Ceramill A-Temp 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. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Attribute | Ceramill A-Temp | PMMA CAD/CAM Disc | Comparison |
|---|---|---|---|
| Manufacturer | Amann Girrbach AG | Polident d.o.o. | N/A |
| 510(k) Number | To be determined (TBD) | K112967 | N/A |
| Attribute | Ceramill A-Temp | PMMA CAD/CAM Disc | Comparison K##### |
| Product Code | EBG | EBG | Same |
| Regulation | |||
| Number | 872.3770 | 872.3770 | Same |
| Regulation Title | Temporary crown and | ||
| bridge resin | Temporary crown and | ||
| bridge resin | Same | ||
| Indications for Use | - Temporary anterior and | ||
| posterior crowns with a | |||
| wearing time of | |||
| maximum three years |
- Temporary anterior and
posterior bridges with a
maximum of two
connected pontics and a
maximum wearing time
of three years - Verifying the fit on the
plaster model/mouth
before the final
restoration | Fabrication of temporary
crowns and bridges. | Similar; both devices are
indicated for the
production of temporary
crowns and bridges with a
maximum wearing period
of three years.
The indications for use of
Ceramill A-Temp fall
within the intended use of
PMMA CAD/CAM Disc.
Both devices are for
prescription only. |
| Mechanism of
Action | Ceramill A-Temp blank
once milled becomes
temporary crowns or
bridges used for
restoration. | PMMA CAD/CAM Disc
blank once milled
becomes temporary
crowns or bridges used for
restoration. | Same |
| Material | Solid
Polymethylmethacrylate
(PMMA)
Colored pigments | Solid
Polymethylmethacrylate
(PMMA)
Colored pigments | Same |
| Residual monomer | Less than 1% residual
monomer | Less than 1% residual
monomer | Same; both devices meet
requirements from ISO
10477:2018¹ (135 MPa | ≥114 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 10477:2018 (≥50). |
| Water solubility | 1 ISO 10477:2018. Dentistry – Polymer-based crown and veneering materials (FDA Recognition Number: 4-248).
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9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Ceramill A-Temp and to show substantial equivalence to the predicate device, Amann Girrbach AG completed of the following non-clinical tests. The Ceramill A-Temp meets all the requirements for overall design and biocompatibility confirming that the design output meets the design inputs and specifications for the device.
The Ceramill A-Temp passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and its substantial equivalence to the subject device:
- . Biocompatibility testing per ISO 10993-1. No cytotoxic effects were observed in presence of the test material extracts. There was no indication that any ingredients/residues of the blank material are released in toxicologically relevant concentrations during the intended dental use.
- . Residual monomer testing – Ceramill A-Temp met requirement from ISO 10477:2018.
- . 3-point bending strength – Ceramill A-Temp met requirement from ISO 10477:2018.
- Water solubility - Ceramill A-Temp met requirement from ISO 10477:2018.
- . Water absorption – Ceramill A-Temp met requirement from ISO 10477:2018.
- . Polishability - Ceramill A-Temp met requirement from ISO 10477:2018.
- Wearing period – 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.
10. Statement of Substantial Equivalence
The Ceramill A-Temp has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Ceramill A-Temp is as safe and effective as the predicate device.
Therefore, the Ceramill A-Temp, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.