Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

AI/ML Overview

The acceptance criteria and study proving device performance are detailed below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device K053427 Fresh Bold)	Reported Device Performance (Dynax® clear, putty, heavy body, light, mono)
Working / Processing time	90 - 120 sec	90 sec
Setting time / Time in the mouth	120 - 140 sec	90 sec
Hardness	42 - 70 Shore A	46 - 70 Shore A
Working humidity	50 %	50 %
Dimensional accuracy	99.9 % - 99.2 %	99.9 % - 99.2 %
Stability (linear dimensional change)	< 0.1 % typical	< 0.2 % typical
Consistency	Type 0 - type 3 DIN EN ISO 4823	Type 0 - type 3 DIN EN ISO 4823

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "a series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life" and that the device meets its product specification.

The data provenance is not explicitly mentioned as country of origin, but the manufacturer is Dreve Dentamid GmbH, located in Unna/Germany. The testing appears to be "in-house."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described focuses on physical and chemical properties of the impression material, not on interpretations by experts.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are not applicable or mentioned, as the testing relates to measurable physical properties rather than subjective interpretations by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document presents a comparison of physical and chemical properties of the device with a predicate device. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. The device is a dental impression material, not an algorithm or AI. Performance is evaluated based on its physical properties.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by standardized physical and chemical property measurements, benchmarked against the acceptable ranges defined by the predicate device and relevant international standards (e.g., ISO 4823). These are objective measurements rather than expert consensus, pathology, or outcomes data in a medical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The development and testing of this dental impression material do not involve a "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device. The ground truth for the product's performance is derived from its adherence to documented specifications and international standards for dental impression materials.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Dreve Dentamid GmbH Rilchard Keen Consultant 1151 Hope Street Stamford, Connecticut 06907-1659 April 13, 2018

Re: K171562

Trade/Device Name: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 22, 2018 Received: March 14, 2018

Dear Richard Keen:

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

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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); 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

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Image /page/2/Picture/0 description: The image shows a circular logo with the word "Dreve" in white letters. The word is centered within the circle. The background of the circle appears to be a dark color, possibly black or a dark shade of gray. The logo has a simple and clean design.

Indications for Use

Dreve Dentamid

510(k) Number (if known): K171562

Device Name:

Dynax Dental Impression Material:

. Dynax clear
Dynax putty
Dynax heavy body
Dynax light
Dynax mono

Indications for Use:

Dynax Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Prescription Use(21 CFR Part 801 Subpart D)
-------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

and/or

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/2/Picture/17 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV Rheinland Group". The bottom of the logo contains the text "ISO 9001 < 119 15423". The logo is black and white.

(Division Sign-Off)

Image /page/2/Picture/19 description: The image shows a logo for VDDI Dental Solutions German Manufacture. The logo features the letters VDDI in bold, followed by the words "Dental Solutions" and "German Manufacture" in smaller fonts. To the left of the text is a graphic element that appears to be a stylized representation of a dental-related object. The overall design is simple and professional, conveying a sense of quality and reliability.

Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel .: +49 2303 8807 - 0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti 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

Over-The-Counter Use

(21 CFR Part 801 Subpart C)

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Postbank Dortmund Kto .- Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469

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K171562

510(k) Summary

Dreve Dentamid

Sponsor:	Dreve Dentamid GmbHDr. Reiner Altmann(Head of Quality Management &Regulatory Affairs)Max-Planck-Str. 3159423 Unna/GermanyPhone: +49 2303 8807 14Email: reiner.altmann@dreve.de
Consultant:	Mr. Richard KeenCompliance Consultants1151 Hope StreetStamford, CT 06907-1659Phone: 203 329 2700 F 203 329 2345Email: rkeen@fda-complianceconsultants.com
Date:	April 12th, 2018
510(k) number:	K171562
Proprietary Name:	Dynax® clear, models D6121 & D6122Dynax® putty, model D6101Dynax® heavy body, models D6112 & 6113Dynax® light, models D6103 & 6104Dynax® mono, models D6106 & 6107
Common Name:	Dental Impression Material
Device Classification Name:	Impression material
Classification Number:	21 CFR 872.3660
Product Code:	ELW
Reviewing Group:	Dental
Device Classification:	Class 2 per 21 CFR 872.3660
Establishment registration No.	1000486347
Predicate Device:	K053427 Fresh Bold, Impression material

Trademark Notice: All Trademarks used other than those of Dreve DentamidTrademark Notice: All Trademarks used other than those of Dreve Dentamid GmbH are registered to their respective owners.

Image /page/3/Picture/5 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV NORD CERT GmbH". The outer ring of the logo contains the text "ISO 9001 / ISO 13485".

Image /page/3/Picture/6 description: The image contains a logo with the text "VDDI" in bold letters. Below the text, there are smaller words that say "Dental Solutions German Manufactur". To the left of the text, there is a partial image of a circular design.

Image /page/3/Picture/7 description: The image shows the letters B, V, and D in a bold, sans-serif font. Below the letters, there is some smaller text that reads "Koop erative Mitglied im Bundesve stand Dentalhandel e.V." The text is slightly blurry, but the letters BVD are clear and prominent.

Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712

Sparkasse Unna Kto.-Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 000043000

Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400

Page 1 of 5

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Image /page/4/Picture/0 description: The image shows a logo for Dreve Dentamid. The logo features a red circle with the word "Dreve" in white letters inside the circle. Below the circle, the words "Dreve Dentamid" are written in a larger, bold font.

Device Description

Intended Use

Dental Impression Material on the basis of vinylpolysiloxane

Indications for Use:

Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Technological Characteristics

Design

The Dynax® Dental Impression Materials are similar in design to the predicate listed above. Same as the predicate the Dynax® Dental Impression Materials are intended to reproduce the structure of a patient's teeth and gums to make crowns, bridges, occlusal and dental implant impressions. They use similar technological characteristics and principles. Both materials are two component silicones being mixed in 1:1 ratio to start the vulcanizing process.

Material

As the predicate material the Dynax® Dental Impression Materials are based on mixtures of vinyl terminated polydimethylsiloxanes and filler materials with platinum catalyst and methylhydrosiloxane dimethylsiloxane copolymers. An assessment of the biocompatibility according to FDA Recognized Consensus Standard ISO 10993-1 is included in this application. As a result of this assessment/testing we conclude that the device is safe for its intended use and does not show any unacceptable risks for users, patients and third parties.

This is a prescription only material. The labeling and working instructions are designed for health care professionals.

Testing

The Dynax® Dental Impression Materials have been designed, developed, tested and produced according to ISO 13485; CAN/CSA ISO 13485 and European Medical Device Directive 93/42/EEC. The quality system is certified by a Notified Body.

Image /page/4/Picture/15 description: The image shows a logo with the text "VDDI Dental Solutions German Manufactu". The logo also includes a circular graphic element to the left of the text. The graphic element appears to be an abstract representation of dental equipment or a related symbol. The text is stacked vertically, with "VDDI" at the top in a larger font size, followed by "Dental Solutions" and "German Manufactu" in smaller fonts.

Image /page/4/Picture/16 description: The image shows the letters B, V, and D in bold font. The letters are vertically aligned and have a curved line above them. Below the letters is the text "Kooperatives Mitglied im Bundesverband des deutschen K".

Dreve Dentamid GmhH Max-Planck-Straße 31 59423 Unna/Germany Tel .: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti 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

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Postbank Dortmund Kto.-Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469

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Image /page/5/Picture/0 description: The image shows a red circle with the word "Dreve" written in white letters in the center. The circle has a thin white border around it. The background is white and slightly blurry.

Testing has confirmed that these devices meet their 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.

Substantial Equivalence

Information provided in this application shows that the product is substantially equivalent to the predicate device in intended use, performance, materials and application. The differences between these devices are incidental and not significant and do not raise new questions of safety or effectiveness.

Safety and Effectiveness

There are no substantial differences between the Dynax® (clear, putty, heavy body, light, mono) and the predicate device: the K053427 Fresh Bold, Impression material. In fact, the Dynax® (clear, putty, heavy body, light, mono) and the predicate device: the K053427 Fresh Bold, Impression material are virtually identical with minor exceptions.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. The Dynax® (clear, putty, heavy body, light, mono) has benefited from design, development, testing and production procedures that conform to our in-house quality systems.

Harmonized Test

This device is the same (within the definition of design controls) as the device cleared in K053427 - with the addition of qualifying this device to the indicated harmonized standards. This device may be used interchangeably with the predicate.

Comparable Parameter	Dynax® (clear, putty,heavy body, light, mono)	K053427FreshBold.Impression material
Intended Use	Dental Impression Materialon the basis ofvinylpolysiloxane	The intended use of thismaterial is for a trained dentalto reproduce the structure ofpatient's teeth and gums tomake crowns, bridges,occlusal and dental implantimpressions.
Indications for Use	Dynax® Dental ImpressionMaterial is intended to beplaced on a preformedimpression tray and used toreproduce the structure of apatient's teeth and gums.	Fresh, Dental Impressionmaterial is intended for usewith all crowns, bridges,occlusal and dental implantimpression techniques toreproduce the structure of apatient's teeth and gums.
Working / Processing time	90 sec	90 - 120 sec
Setting time / Time in themouth	90 sec	120 - 140 sec
Hardness	46 - 70 Shore A	42 - 70 Shore A
Working humidity	50 %	50 %
Dimensional accuracy	99.9 % - 99.2 %	99.9 % - 99.2 %
Stability (lineardimensional change)	< 0.2 % typical	< 0.1 % typical
Consistency	Type 0 - type 3DIN EN ISO 4823	Type 0 - type 3DIN EN ISO 4823
Design	Dynax® putty is sold intubs of 2 x 35 ml and2 x 450 ml.Dynax® light, mono,heavy body and clear aresold in 50 ml doublecartridges.	Fresh Bold liquid puttyimpression system is soldin tubs of 2 x 450 ml.Fresh Bold light body,monophase, heavy bodyand clear bite are sold inpacks of 2 x 50 ml doublecartridges plus mixingcanulas
Material	Dynax® putty, light, monoand heavy body:Mixture of vinyl terminatedpolydimethylsiloxanes andfiller materials with platinumcatalyst andmethylhydrosiloxanedimethylsiloxanecopolymers.Dynax® clear:Mixture of vinyl terminatedpolydi-methylsiloxanes andsilicic acid with platinumcatalyst and methyl-hydrosiloxanedimethylsiloxanecopolymers.	Fresh Bold liquid putty, lightbody, monophase and heavybody:Mixture of vinyl terminatedpolydimethylsiloxanes andfiller materials with platinumcatalyst andmethylhydrosiloxanedimethylsiloxane copolymers,Fresh Bold clear bite:Mixture of vinyl terminatedpolydi-methylsiloxanes andsilicic acid with platinumcatalyst and methyl-hydrosiloxanedimethylsiloxane copolymers.
Chemical Description	Room temperaturevulcanizing 2-componentssilicone	Room temperaturevulcanizing 2-componentssilicone

Summary of the Technological Characteristics of this Device compared to the Predicate:

Image /page/5/Picture/12 description: The image is a logo for TUV NORD CERT GmbH. The logo is circular with the text "TUV NORD" at the top, followed by "TUV NORD CERT GmbH" in smaller text. The outer ring of the circle contains the text "ISO 9001 / ISO 13485".

Image /page/5/Picture/13 description: The image shows a logo with the text "VDDI Dental Solutions German Manufacturing". The logo also includes a circular graphic element that is partially filled in with black, creating a crescent shape. The text is positioned to the right of the graphic, with "VDDI" on the top line and "Dental Solutions German Manufacturing" on the lines below.

Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel .: +49 2303 8807 - 0 Fax: +49 2303 8807-55

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti Sitz: 59423 Unna E-Mail: dentamid@dreve.de 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

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Postbank Dortmund Kto .- Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469

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Image /page/6/Picture/0 description: The image shows the Dreve Dentamid logo. The logo features a red circle with the word "Dreve" written in white letters inside the circle. Below the circle, the words "Dreve Dentamid" are written in a larger, bold font.

Image /page/6/Picture/2 description: The image is a circular logo or certification mark. The text "TUV NORD" is prominently displayed at the top. Below that, the text "TUV NORD CERT GmbH" is present. The text "ISO 9001 / ISO 13485" is written around the bottom edge of the circle.

VDDI

Image /page/6/Picture/4 description: The image shows the letters B, V, and D in a row. Below the letters is the text "Kooperatives Mitglied Im Bundesverband Dentalhandel e.V." The letters are in a bold sans-serif font. There are vertical lines above each of the letters.

Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti 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 032235400

Postbank Dortmund Kto.-Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF
IBAN: DE 42 44010046 0006493469

Page 4 of 5

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Image /page/7/Picture/0 description: The image shows the Dreve Dentamid logo. The logo features the word "Dreve" in white letters inside a red circle. Below the circle, the words "Dreve Dentamid" are written in a larger, bold font.

Method of manipulation	Perforated impression trays	Perforated impression trays
Consensus standards	EN ISO 13485: 2012 +AC:2012ISO 7405: 2nd EditionISO 4823: 4th EditionISO 14971: 2nd EditionISO 10993-1: 2009	EN ISO 13485: 2012 +AC:2012ISO 7405: 2nd EditionISO 4823: 4th EditionISO 14971: 2nd EditionISO 10993-1: 2009

Conclusion

The technological characteristics of the subject device and the predicate are virtually identical and both devices have the same intended use. Any noted differences between. Dynax® Dental Impression Material and the predicate do not raise new questions of safety or effectiveness.

Dynax® Dental Impression Material is substantially equivalent to the predicate Fresh Bold, Impression material based on design, material, performance, chemical description and consensus standards.

Image /page/7/Picture/5 description: The image is a circular logo that is divided into two halves. The top left half is black and contains the text "TUV NORD" in white letters. Below that is the text "TUV NORD CERT" in smaller letters. The bottom half of the logo is white and contains the text "ISO 9001 / ISO 13485" in black letters. The text is arranged in a circular fashion around the edge of the logo.

Image /page/7/Picture/6 description: The image shows a logo with the text "VDDI Dental Solutions German Manufacturer". The logo features a stylized, abstract design resembling a partial circle or crescent shape on the left side. The text is arranged in a vertical stack, with "VDDI" in a larger, bolder font at the top, followed by "Dental Solutions" and "German Manufacturer" in smaller fonts below. The overall design is clean and professional, suggesting a company in the dental industry with a German manufacturing base.

Image /page/7/Picture/7 description: The image shows the letters BVD in a bold, sans-serif font. Below the letters, there is smaller text that reads "Kooperatives Mitglied Im Bundesverband Dentalhandel e V.". The letters are vertically aligned and appear to be part of a logo or heading.

Dreve Dentamid GmbH Max-Planck-Straße 31 59423 Unna/Germany Tel.: +49 2303 8807-0 Fax: +49 2303 8807-55 E-Mail: dentamid@dreve.de

Internet: www.dreve.com/dentamid Lieferadresse: Einsteinstr. 36 Geschäftsführer: Dr. Volker Dreve, Dino Marchetti Sitz: 59423 Unna Reg.-Gericht: Hamm HRB 3712

Sparkasse Unna Kto.-Nr. 43 000 BLZ 443 500 60 BIC: WELADED1UNN IBAN: DE 26 44350060 000043000

Commerzbank AG Dortmund Kto.-Nr. 03 222 354 00 BLZ 440 800 50 BIC: DRESDEFF440 IBAN: DE 35 44080050 0322235400

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Postbank Dortmund Kto.-Nr. 6 493 469 BLZ 440 100 46 BIC: PBNKDEFF IBAN: DE 42 44010046 0006493469

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).