Who is the manufacturer of Ceramill A-Temp?

Amann Girrbach AG filed the 510(k) submission for Ceramill A-Temp (K191843).

What is the FDA product code for Ceramill A-Temp?

EBG. It is classified under 21 CFR 872.3770 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Ceramill A-Temp?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Ceramill A-Temp?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

K080556 — ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES · Merz Dental GmbH · May 2, 2008
K190217 — Aidite PMMA · Aidite (Qinhuangdao) Technology Co., Ltd. · Dec 17, 2020
K131664 — COPRA TEMP PMMA-DISK · White Peaks Dental Systems GmbH & Co. KG · Dec 18, 2013
K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT · Zirkonzahn GmbH · Jun 28, 2018
K201563 — PuRE PMMA Disc · Quest Dental USA Corp. · Apr 9, 2021

Submission Summary (Full Text)

{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 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ 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 (<5). | | Shape, sizes | Available in round, arch shapes respectively of 98 and 71 mm with three (3) different height (14, 16, | Available only in round shape from 95 to 98.5mm. | Similar; the arch shape and/or the block shape do not introduce any additional safety or | | Attribute | Ceramill A-Temp | PMMA CAD/CAM Disc | Comparison | | | 20 mm). Also available in block shape 40 or 55mm by length and 19mm by width | | efficacy concerns. Dimensions of the round form are in the same range. | | 3-point bending strength | >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 | <0.6 $µg/mm³$ | The predicate is on the US market and is consequently assumed to be in compliance with ISO 10477:2018 requirement for water solubility (≤7.5). | Similar; potential minor variance does not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO 10477:2018 (≤7.5). | | Water absorption | <25 $µg/mm³$ | The predicate is on the US market and is consequently assumed to be in compliance with ISO 10477:2018 requirement for water absorption (≤40). | Similar; potential minor variance does not introduce additional safety or efficacy concerns. Both devices meet requirements from ISO 10477:2018 (≤40). | | Sterile | Delivered non-sterile to the dental technician and is not intended to be sterilized by the dental laboratory. | Delivered non-sterile to the dental technician and is not intended to be sterilized by the dental laboratory. | Same | | Single-Use | Yes | Yes | Same | | Complies with ISO 10993-1 | Yes | Yes | Same | #### Table 5A – Comparison of Characteristics {5}------------------------------------------------ 1 ISO 10477:2018. Dentistry – Polymer-based crown and veneering materials (FDA Recognition Number: 4-248). {6}------------------------------------------------ {7}------------------------------------------------ #### 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.