Ceramill A-Temp

K191843 · Amann Girrbach AG · EBG · Oct 4, 2019 · Dental

Device Facts

• Record ID: K191843
• Device Name: Ceramill A-Temp
• Applicant: Amann Girrbach AG
• Product Code: EBG · Dental
• Decision Date: Oct 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Ceramill A-Temp is a PMMA-based CAD/CAM blank used by dental technicians to mill temporary crowns and bridges. The device is supplied as a solid disk (round or arch-form) or block. After milling, the resulting restoration is placed in the patient's mouth to serve as a temporary dental prosthesis for up to three years or to verify fit before final restoration. The device is non-sterile and intended for prescription use. It benefits patients by providing a durable, biocompatible temporary solution during the fabrication of permanent restorations.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), residual monomer content, 3-point bending strength, water solubility, water absorption, polishability, and shelf-life stability. All results met ISO 10477:2018 requirements.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) with colored pigments. Form factor: Disks (98mm, 71mm) or blocks (40mm/55mm length). Mechanical properties: 3-point bending strength >135 MPa. Standards: ISO 10477:2018, ISO 10993-1. Non-sterile, single-use.

Indications for Use

Indicated for patients requiring temporary anterior and posterior crowns or bridges (up to two connected pontics) for a maximum duration of three years, and for verifying fit on plaster models or in the mouth prior to final restoration.

Regulatory Classification

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.

Predicate Devices

• PMMA CAD/CAM Disc (K112967)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [e-mail]

Office number: + 49 (7231) 957-260

#### 2. Submission Correspondent

Emergo Europe Consulting

Prinsessegracht 20

The Hague, 2514 AP

THE NETHERLANDS

Office Phone: [phone] / Direct: [phone]

Contact: Rachel Paul

Title: Senior Consultant, QA & RA

Email: [e-mail]

Cell Phone : [phone]

#### 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<br>Number | 872.3770 | 872.3770 | Same |
| Regulation Title | Temporary crown and<br>bridge resin | Temporary crown and<br>bridge resin | Same |
| Indications for Use | - Temporary anterior and<br>posterior crowns with a<br>wearing time of<br>maximum three years<br>- Temporary anterior and<br>posterior bridges with a<br>maximum of two<br>connected pontics and a<br>maximum wearing time<br>of three years<br>- Verifying the fit on the<br>plaster model/mouth<br>before the final<br>restoration | Fabrication of temporary<br>crowns and bridges. | Similar; both devices are<br>indicated for the<br>production of temporary<br>crowns and bridges with a<br>maximum wearing period<br>of three years.<br>The indications for use of<br>Ceramill A-Temp fall<br>within the intended use of<br>PMMA CAD/CAM Disc.<br>Both devices are for<br>prescription only. |
| Mechanism of<br>Action | Ceramill A-Temp blank<br>once milled becomes<br>temporary crowns or<br>bridges used for<br>restoration. | PMMA CAD/CAM Disc<br>blank once milled<br>becomes temporary<br>crowns or bridges used for<br>restoration. | Same |
| Material | Solid<br>Polymethylmethacrylate<br>(PMMA)<br>Colored pigments | Solid<br>Polymethylmethacrylate<br>(PMMA)<br>Colored pigments | Same |
| Residual monomer | Less than 1% residual<br>monomer | Less than 1% residual<br>monomer | Same; both devices meet<br>requirements from ISO<br>10477:2018¹ (<5). |
| Shape, sizes | Available in round, arch<br>shapes respectively of 98<br>and 71 mm with three (3)<br>different height (14, 16, | Available only in round<br>shape from 95 to 98.5mm. | Similar; the arch shape<br>and/or the block shape do<br>not introduce any<br>additional safety or |
| Attribute | Ceramill A-Temp | PMMA CAD/CAM Disc | Comparison |
| | 20 mm). Also available in<br>block shape 40 or 55mm<br>by length and 19mm by<br>width | | efficacy concerns.<br>Dimensions of the round<br>form are in the same<br>range. |
| 3-point bending<br>strength | >135 MPa | ≥114 MPa | Similar; the specifications<br>are in the same range.<br>This minor variance does<br>not introduce additional<br>safety or efficacy<br>concerns. Both devices<br>meet requirements from<br>ISO 10477:2018 (≥50). |
| Water solubility | <0.6 $µg/mm³$ | The predicate is on the US<br>market and is<br>consequently assumed to<br>be in compliance with ISO<br>10477:2018 requirement<br>for water solubility (≤7.5). | Similar; potential minor<br>variance does not<br>introduce additional<br>safety or efficacy<br>concerns.<br>Both devices meet<br>requirements from ISO<br>10477:2018 (≤7.5). |
| Water absorption | <25 $µg/mm³$ | The predicate is on the US<br>market and is<br>consequently assumed to<br>be in compliance with ISO<br>10477:2018 requirement<br>for water absorption<br>(≤40). | Similar; potential minor<br>variance does not<br>introduce additional<br>safety or efficacy<br>concerns.<br>Both devices meet<br>requirements from ISO<br>10477:2018 (≤40). |
| Sterile | Delivered non-sterile to<br>the dental technician and<br>is not intended to be<br>sterilized by the dental<br>laboratory. | Delivered non-sterile to<br>the dental technician and<br>is not intended to be<br>sterilized by the dental<br>laboratory. | Same |
| Single-Use | Yes | Yes | Same |
| Complies with ISO<br>10993-1 | 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.