Fixtemp C&B

{0}------------------------------------------------ 4/10/2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Dreve Dentamid GmbH Reiner Altmann Head of Quality Management & Regulatory Affairs Max-Planck-Strasse 31 Unna, DE 59423 NRW Re: K171729 Trade/Device Name: Fixtemp C&B Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary crown and bridge resin Regulatory Class: Class II Product Code: EBG Dated: November 17, 2017 Received: November 20, 2017 Dear Reiner Altmann: This letter corrects our substantially equivalent letter of December 13, 2017. 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ #### Page 2 - Reiner Altmann 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner -S Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171729 Device Name Fixtemp® C&B Indications for Use (Describe) Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/1 description: The image features a red circle with the word "Dreve" in white letters at the center. Below the circle, the text "Dreve Dentamid" is displayed in a larger, bold font. The red circle has a white border, providing contrast against the background. | • Submitter: | Dreve Dentamid GmbH<br>Max-Planck-Straße 31<br>Unna, Nordrhein-Westfalen, 59423<br>Germany<br>Establishment Reg. No. 1000486347 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | • Contact: | Dr. Reiner Altmann<br>(Head of Quality Management and<br>Regulatory Affairs)<br>Phone: +49-2303-88070<br>E-mail: reiner.altmann@dreve.de | | • Official Correspondent: | Mr. Michael Breer<br>(Quality Management Representative) | | • Date Prepared | December 12th, 2017 | | • Common Name: | Temporary C&B resin | | • Trade/Device Name: | Fixtemp® C&B | | • Model No.: | D60391, D60392, D603925, D60393, D603935, D60394, D60395, D60396, D60399 | | • Classification Name: | Crown and bridge, Temporary, Resin | | • Device Classification: | Class 2 per 21 CFR 872.3770 | | • Product Code: | EBG | Predicate Device: K102917 FixTemp C&B™ # Device Description Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals. Image /page/3/Picture/7 description: The image contains two logos stacked on top of each other. The top logo is a circular seal with the text "TUV NORD" at the top and "ISO 9001 / ISO 13485" at the bottom. The bottom logo is a circular design with a square shape attached to the right side. Below the logos, the text "Deutsche-Dental-Industrie" is written. Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: info@dreve.de Internet: www.dreve.com Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712 Sparkasse Unna Kto.-Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 0000043000 Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400 Page 1 of 5 Postbank Dortmund Kto .- Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a red circle with a white border. Inside the circle, the word "Dreve" is written in white, sans-serif font. The background is white. Dreve Dentamid The associated accessories include mixing tips as follows: - Trade/Device Name: Mixing tips . - Product code: . EID - Classification name: . Syringe, restorative and impression material - Device classification: Class 1 as per 21 CFR 872,4565 - . Listing No.: D244388 # Indications for Use: e Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges. # Substantial Equivalence Information provided in this application shows that the product is substantially equivalent to the predicate device in indications for use, performance, materials and application. The main difference between these devices is the mixing ratio but the Fixtemp® C&B is substantial equivalent as shown in the substantial equivalence comparison. The difference in the mixing ratio does not alter the intended use of the device. # Technological Characteristics Design The Fixtemp® C&B of Dreve is similar in design to the predicate listed above. Same as the predicate the Fixtemp® C&B is intended to manufacture temporary crowns and bridges, as well as inlays, onlays and veneers. They use similar technological characteristics and principles. Both materials are two component materials being mixed to start the curing process. # Material Same as the predicate material, the Dreve Fixtemp® C&B is based on multifunctional (meth)acrylates, glass powder, aerosil, polyester and catalyst. An assessment of the biocompatibility according to FDA Recognized Consensus Standard DIN EN ISO 7405 / ISO 10993-1 is included in this application. As a result of this assessment/testing we conclude that the device is substantial equivalent. Some chemicals are part of Fixtemp® C&B (Dreve) but not available in the predicate`s composition, but also used in other devices of product code EBG for crown and bridge, temporary, resin like K122039, K033022, K042820 and K013674. Image /page/4/Picture/17 description: The image is a circular logo with the text "TUV NORD" at the top. Below that, it says "TUV NORD CERT GmbH". The logo also contains the text "ISO 9001 / ISO 13485" around the bottom of the circle. The top left quadrant of the circle is black, while the rest is white. B V D Kooperatives Mitglied im Bundesverband Dentalhandel e.V. F-Mail: dentamid@dreve.de nternet: www.dreve.com/dentami ieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712 to .- Nr. 43 000 0000043000 Commerzbank AG Dortmun Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400 Page 2 of 5 DANI. DE 47 44010046 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a red circle with a white border. Inside the circle, the word "Drewe" is written in white, bold letters. The background is white. #### Testing Dreve Dentamid The Fixtemp® C&B has benefited from design, development, testing and production procedures that are being certified according to ISO 13485; CAN/CSA ISO 13485 and European Medical Device Directive 93/42/EEC by a Notified Body. Testing has confirmed that this device meets its product specification. A series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life. The testing also demonstrated that the specification is substantial equivalent as the predicate and for details please refer to the substantial equivalence comparison. Furthermore the material is: - patient-contacting o - non-sterile . # Summary non-clinical performance data | CHARACTERISTICS | Comments | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials1 | Mixture of multifunctional (meth)acrylates, glass powder, aerosil, polyester and catalyst.<br>The used raw materials are state-of-the-art and are not<br>known to have unacceptable risks or dangers when used as ingredients. | | Chemical Description | Self-curing resin (radical polymerization) | | Method of<br>manipulation | Impression or thermoforming blank | | Flow properties | Paste-like liquid | | Working /<br>Processing time | ≥ 45 sec | | Curing time in the<br>mouth-flexible<br>phase | ≥ 2 - 3 min | | Setting time | ≥ 6 min | | Hardness | 1h: ≥ 75 Shore D<br>24h: ≥ 80 Shore D | | Compressive<br>strength | ≥ 200 MPa according to DIN EN ISO 4049:2010. | | Flexural strength | ≥ 60 MPa according to DIN EN ISO 4049:2010. | | E-modulus | > 1500 according to DIN EN ISO 4049:2010 | | Water absorption | Pass according to DIN EN ISO 4049:2010. | | Radiopacity | ≥ 1.00 mm aluminium/mm material according to DIN EN<br>ISO 4049:2010. | | Safety - toxic | The cytotoxicity of cured Fixtemp® C&B was tested based<br>on ISO 10993-5 by the independent laboratory Toxikon.<br>The potential biological reactivity of a mammalian cell<br>culture (mouse fibroblasts L929) in response to the test<br>article Fixtemp® C&B was determined. There was no<br>biological reactivity (grade 0) of the cells exposed to the<br>test article. | | | The test item Fixtemp® C&B (Lot# FE140814-27C -<br>601606x0) was considered to have no cytotoxic potential<br>and to meet the requirements of ISO 10993-5. For details<br>please refer to the test report "Toxikon Europe Final GLP<br>Report: 17-01389-G1" in section B11. | | Safety - carcinogenic | During the application uncured Fixtemp® C&B has direct<br>contact with the patients' dentin and mucosal membrane.<br>The biological risk during the application is negligible<br>because of the short intraoral time < 3min. | | | Different evaluations and assessments have been made for<br>cured Fixtemp® C&B and they have shown that there is no<br>evidence for causing cancer within the time period of use<br>in the patients mouth for up to 29 days. | | Safety - mutagenic | During the application uncured Fixtemp® C&B has direct<br>contact with the patients' dentin and mucosal membrane.<br>The biological risk during the application is negligible<br>because of the short intraoral time < 3min. | | | Different evaluations and assessments have been made for<br>cured Fixtemp® C&B and they have shown that there is no<br>evidence for mutagenic reactions within the time period of<br>use in the patients mouth for up to 29 days. | | Safety - irritating | During the application uncured Fixtemp® C&B has direct<br>contact with the patients' dentin and mucosal membrane.<br>The biological risk during the application is negligible<br>because of the short intraoral time < 3min. | | | Different evaluations and assessments have been made for<br>cured Fixtemp® C&B and they have shown that there is no<br>evidence for irritation within the time period of use in the<br>patients mouth for up to 29 days. | Image /page/5/Picture/10 description: The image contains two logos. The first logo is a circular seal with the text "TUV NORD" at the top and "ISO 9001 / ISO 13485" at the bottom. The second logo is a stylized design featuring a circle with a geometric shape inside, resembling a stylized letter or symbol. Image /page/5/Picture/11 description: The image shows a logo for "Deutsche-Dental-Industrie". Below the text are three vertical lines that are curved at the top and bottom. The letters "B", "V", and "D" are placed between the lines. Below the lines is the text "Kooperatives Mitglied im". Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel .: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: info@dreve.de B6. Internet: www.dreve.com Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve Sitz: 59423 Unna Reg - Gericht: Hamm HRB 3712 Sparkasse Unna Kto.-Nr. 43 000 BI 7 443 500 60 BIC: WELADED 1UNN 1BAN: DE 26 44350060 0000043000 1 For a detailed formulation for Fixtemp® C&B of Dreve Dentamid please refer to table 1 Section Commerzbank AG Dortmund Kto -Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400 Page 3 of 6 Postbank Dortmund Kto .- Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a red circle with a white border. Inside the circle, the word "Dreve" is written in white, sans-serif font. The word is centered horizontally and vertically within the circle. The background of the image is plain white. #### Dreve Dentamid Image /page/6/Picture/3 description: The image shows two logos. The top logo is the "TUV NORD" certification mark, indicating compliance with ISO 9001 and ISO 13485 standards. The bottom logo is for "Deutsche Dental-Industrie", featuring a stylized circle and a square with a triangle cut out, representing the German dental industry association. Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: info@dreve de Internet: www.dreve.com Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712 Sparkasse Unna Kto.-Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 0000043000 Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400 Postbank Dortmund Kto.-Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469 Page 4 of 5 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a red circle with the word "Dreve" written in white letters in the center. The circle has a white border around it. The background of the image is white. | | Dreve Dentamid | | |--|----------------|--| |--|----------------|--| | Safety - sensitizing | During the application uncured Fixtemp® C&B has direct<br>contact with the patients' dentin and mucosal membrane.<br>The biological risk during the application is negligible<br>because of the short intraoral time < 3min. | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Different evaluations and assessments have been made for<br>cured Fixtemp® C&B and they have shown that there is no<br>evidence for sensitization within the time period of use in<br>the patients mouth for up to 29 days. | | Keeping (storage)<br>quantities | The results of stability tests at 23 °C/37 °C justify to assume<br>a shelf life of 2 years for Fixtemp® C&B. | | Duration | Short term contact < 30 days | | Type of contact | oral cavity as far as the pharynx | | Conformance to<br>consensus standard | EN ISO 13485:2012 | | | ISO 7405:2008 | | | ISO 10993-1:2009 | | | ISO 14971:2007 | #### Conclusion There are no substantial differences between the Fixtemp® C&B defined in this 510(k) submission and other legally marketed devices in the United States. The device is substantially equivalent to predicate device FixTemp C&B™ listed by company Exacta Dental Direct. The materials function similar and have the same indications for use. Same as the predicate the Fixtemp® C&B is state-of-the-art resin based material used to fabricate temporary crowns and bridges by intra-oral application and extra-oral final polymerization. #### Dreve Dentamid GmbH Signature i.A. Dr. Reiner Altmann (Head of Quality Management / Quality Control / Regulatory Affairs & Safety Representative for Medical Devices) Image /page/7/Picture/9 description: The image shows two logos stacked on top of each other. The top logo is a circular seal with the text "TUV NORD" and "ISO 9001 / ISO 13485". The bottom logo is a circular design with a square shape attached to the right side. Below the logos, the text "Deutsche-Dental-Industrie" is visible. Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: info@dreve.de Internet: www.dreve.com Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712 Sparkasse Unna Kto .- Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 0000043000 Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400 Page 5 of 5 Postbank Dortmund Kto .- Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469