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

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ceramill A-Temp device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Requirement)	Ceramill A-Temp Performance	Comparison to Predicate Device
Residual monomer (ISO 10477:2018 requirement: < 5%)	Less than 1%	Meets requirement and is similar to predicate.
3-point bending strength (ISO 10477:2018 requirement: ≥ 50 MPa)	> 135 MPa	Similar to predicate (≥ 114 MPa); both exceed requirement.
Water solubility (ISO 10477:2018 requirement: ≤ 7.5 µg/mm³)	< 0.6 µg/mm³	Similar to predicate (assumed to meet ISO); both meet requirement.
Water absorption (ISO 10477:2018 requirement: ≤ 40 µg/mm³)	< 25 µg/mm³	Similar to predicate (assumed to meet ISO); both meet requirement.
Polishability (ISO 10477:2018)	Met requirement	Not explicitly compared to predicate, but met requirement.
Biocompatibility (ISO 10993-1)	No cytotoxic effects observed. Ingredients/residues not released in toxicologically relevant concentrations.	Met requirement and similar to predicate.
Wearing period	Maximum of three years	Similar to predicate.
Shelf Life	Key characteristics do not degrade after four years of storage.	Not explicitly compared to predicate, but demonstrated.

Study Details:

This submission describes non-clinical performance testing to demonstrate the safety and effectiveness of the Ceramill A-Temp and its substantial equivalence to a predicate device (K112967, PMMA CAD/CAM Disc).

Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each individual non-clinical test (e.g., how many samples were used for bending strength testing).
- The data provenance is from non-clinical laboratory testing performed by Amann Girrbach AG. The country of origin of the testing is not explicitly stated but implies testing by the manufacturer (Amann Girrbach AG, based in Austria) or a contracted lab. It is retrospective in the sense that the testing was completed prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- No human "experts" in the sense of clinical decision-making were involved in establishing ground truth for these non-clinical tests. The "ground truth" for these tests is defined by international and national standards (e.g., ISO 10477:2018, ISO 10993-1) and internal requirements. Scientific and engineering experts set these standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is non-clinical performance testing against pre-defined engineering and material standards, not a clinical trial requiring human adjudication of results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not performed. This device is a dental material (temporary crown and bridge resin) and does not involve AI or human "readers" in its application.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a material device, not an algorithm, so this concept is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference standard for this non-clinical testing is based on International and National Standards (specifically ISO 10477:2018 for dental polymer-based materials and ISO 10993-1 for biocompatibility) and internal material specifications.
The sample size for the training set:
- This concept is not applicable. This is a physical dental material, not an AI/machine learning algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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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 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
RegulationNumber	872.3770	872.3770	Same
Regulation Title	Temporary crown andbridge resin	Temporary crown andbridge resin	Same
Indications for Use	- Temporary anterior andposterior crowns with awearing time ofmaximum three years- Temporary anterior andposterior bridges with amaximum of twoconnected pontics and amaximum wearing timeof three years- Verifying the fit on theplaster model/mouthbefore the finalrestoration	Fabrication of temporarycrowns and bridges.	Similar; both devices areindicated for theproduction of temporarycrowns and bridges with amaximum wearing periodof three years.The indications for use ofCeramill A-Temp fallwithin the intended use ofPMMA CAD/CAM Disc.Both devices are forprescription only.
Mechanism ofAction	Ceramill A-Temp blankonce milled becomestemporary crowns orbridges used forrestoration.	PMMA CAD/CAM Discblank once milledbecomes temporarycrowns or bridges used forrestoration.	Same
Material	SolidPolymethylmethacrylate(PMMA)Colored pigments	SolidPolymethylmethacrylate(PMMA)Colored pigments	Same
Residual monomer	Less than 1% residualmonomer	Less than 1% residualmonomer	Same; both devices meetrequirements from ISO10477:2018¹ (<5).
Shape, sizes	Available in round, archshapes respectively of 98and 71 mm with three (3)different height (14, 16,	Available only in roundshape from 95 to 98.5mm.	Similar; the arch shapeand/or the block shape donot introduce anyadditional safety or
Attribute	Ceramill A-Temp	PMMA CAD/CAM Disc	Comparison
	20 mm). Also available inblock shape 40 or 55mmby length and 19mm bywidth		efficacy concerns.Dimensions of the roundform are in the samerange.
3-point bendingstrength	>135 MPa	≥114 MPa	Similar; the specificationsare in the same range.This minor variance doesnot introduce additionalsafety or efficacyconcerns. Both devicesmeet requirements fromISO 10477:2018 (≥50).
Water solubility	<0.6 $µg/mm³$	The predicate is on the USmarket and isconsequently assumed tobe in compliance with ISO10477:2018 requirementfor water solubility (≤7.5).	Similar; potential minorvariance does notintroduce additionalsafety or efficacyconcerns.Both devices meetrequirements from ISO10477:2018 (≤7.5).
Water absorption	<25 $µg/mm³$	The predicate is on the USmarket and isconsequently assumed tobe in compliance with ISO10477:2018 requirementfor water absorption(≤40).	Similar; potential minorvariance does notintroduce additionalsafety or efficacyconcerns.Both devices meetrequirements from ISO10477:2018 (≤40).
Sterile	Delivered non-sterile tothe dental technician andis not intended to besterilized by the dentallaboratory.	Delivered non-sterile tothe dental technician andis not intended to besterilized by the dentallaboratory.	Same
Single-Use	Yes	Yes	Same
Complies with ISO10993-1	Yes	Yes	Same

Table 5A – Comparison of Characteristics

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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.

Regulation Number and Section

§ 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.