Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser.

Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored.

Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored.

Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the dental impression materials Rapid HB, Rapid LB, and Rapid MB. It outlines the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices, focusing on meeting ISO 4823 standards and comparative performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on fulfilling the requirements of the FDA-recognized standard ISO 4823 and demonstrating similar performance to predicate devices. The document explicitly states: "In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823." and "The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."

The specific metrics tested and their performance relative to acceptance criteria are summarized below:

Acceptance Criteria (Based on ISO 4823 & Predicate Performance)	Reported Device Performance (Rapid HB, LB, MB)
Fulfill requirements of FDA recognized standard ISO 4823: Dentistry - Elastomeric Impression Materials	Fulfilled. "In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823." "The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823."
Consistency (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding consistency... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Contact Angle (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding contact angle... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Working Time (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding working time... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Intraoral Setting Time (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding intraoral setting time... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Recovery from Deformation (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding recovery from deformation... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Strain in Compression (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding strain in compression... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Detail Reproduction (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding detail reproduction... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Compatibility with Gypsum Type 3 / Type 4 (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding compatibility with gypsum type 3 / type 4... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Linear Dimensional Change (Similar to predicate devices)	Similar. Performance "was compared to the predicate devices ... regarding linear dimensional change... The results... are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."
Biocompatibility (According to ISO 10993 series and ISO 7405)	Safe. "The conclusion of the assessment is that Rapid HB, Rapid LB and Rapid MB are safe for their intended use."

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

The document does not specify the exact sample sizes for the "in vitro testing" conducted for each physical and mechanical property. It only states that the testing was "in vitro." This implies the data provenance is from laboratory tests rather than human clinical data. The country of origin for the testing is not explicitly stated, but the submitter is "3M Deutschland GmbH" from Germany.

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

This information is not applicable. The study described is a non-clinical, in vitro performance study of dental impression materials against established standards and predicate devices, not a study involving human diagnostic interpretation or ground truth established by medical experts for a test set. The biocompatibility assessment was conducted by a "board-certified toxicologist."

4. Adjudication Method for the Test Set

This information is not applicable, as the study is a non-clinical performance and biocompatibility assessment, not a clinical study involving adjudication of human read data.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the physical, mechanical, and biological properties of the impression material itself, not on the effectiveness of human readers using or interpreting data from the device.

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

This question is not applicable. The device is a dental impression material, not an AI algorithm or software. The performance assessment is inherently "standalone" in the sense that it evaluates the material properties directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing of physical and mechanical properties, the "ground truth" is defined by the requirements and methodologies outlined in the FDA recognized standard ISO 4823: Dentistry - Elastomeric Impression Materials, as well as the performance characteristics of the legally marketed predicate devices. For biocompatibility, the "ground truth" relies on the standards and guidance documents for biological evaluation of medical devices (ISO 10993 series and ISO 7405).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a training set as this is a non-clinical performance study of a physical material, not a machine learning or AI model that requires training data.

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 and study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

3M Deutschland GmbH % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K173318

Trade/Device Name: Rapid HB, Rapid LB, Rapid MB Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: Class II Product Code: ELW Dated: October 18, 2017 Received: October 20, 2017

Dear Mr. Mark Job:

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. Isting 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.

October 31, 2017

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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for 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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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Name, Title, Office	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name Rapid HB Rapid LB Rapid MB

Indications for Use (Describe)

· Impressions of inlay, onlay, veneer, crown, and bridge preparations

· Fixation and implant impressions

RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.

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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3M Deutschland GmbH

Carl-Schurz-Straße 1 41453 Neuss Germany

Postal Address: ESPE Platz 82229 Seefeld Germany

☎+49 (0)8152 700-0 鳥+49 (0)8152 700-1366 Internet: www.3M.de/OralCare E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179

510(k) Summary K173318

Submitter:	3M Deutschland GmbHESPE Platz82229 SeefeldGermanyEstablishment Registration Number: 9611385
Contact Person	Ruediger FrankeRegulatory Affairs SpecialistPhone: +49-8152-700 1802Fax: +49-8152-700 1869

Phone: +49-8152-700 1602
Fax: +49-8152-700 1869
e-mail: ruediger.franke@3M.com
Date: October 4. 2017

Trade Name:	Rapid HB
	Rapid LB
	Rapid MB

Common Name: ........................................ Polyether impression material

Classification Name:.......................................................................................................................................................... ..............................................................................................................................................................................

Device Class: ................................................................................................................................................................

Predicate Devices ....................... Impregum Penta Soft Quick Step HB (K032001) .............................................................................................................................................................................. ..............................................................................................................................................................................

Description of Device

Sitz: 41453 Neuss · Handelsregister: B 1878 Amtsgericht Neuss Geschäftsführer: Prof. Dr. Joerg Dederichs, Christiane Grün, Nicolas Jennepin, Michael Peters Vorsitzende der Geschäftsführung: Christiane Grün; Vorsitzender des Aufsichtsrates: Günter Gressler

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Applicable Standards for Product Tests

. ISO 4823: Dentistry - Dentistry - Elastomeric Impression Materials

Indications for Use for Rapid HB, Rapid LB and Rapid MB

· Impressions of inlay, onlay, veneer, crown, and bridge preparations
Fixation and implant impressions

RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and doubleunit preparations.

Comparison

Rapid HB, Rapid LB and Rapid MB were compared to Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB regarding indications for use, intended use, composition technology and physical and mechanical properties.

The tables below summarize the indications and technology of Rapid HB, Rapid LB and Rapid MB and predicate devices:

IndicationsComparison	Rapid HBRapid LBRapid MB	Predicate Devices (K032001)
Indications forUse(from theIndications forUse form)	• Impressions of inlay,onlay, veneer, crown, andbridge preparations• Fixation and implantimpressionsRAPID HB, MB and LB areespecially suitable fortaking impressions ofsingle-unit and double-unitpreparations.	Impregum Penta Soft Quick StepHBPoly Q Penta H:Tray material for dual phaseimpression techniques.Impregum Soft Quick Step LBPoly Q Garant L:Wash material for dual phaseimpression techniques.Impregum Penta Soft Quick StepMBPoly Q Penta M:Impression material for monophasetechnique.
Intended Use	Intended to be placed on apreformed impression trayand used to reproduce thestructure of a patient's teethand gums	Intended to be placed on apreformed impression tray and usedto reproduce the structure of apatient's teeth and gums

Table Comparison of indications

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The differences between the indications of the Rapid materials and the predicate devices are not critical to the intended clinical use because the Rapid indications described the clinical case whereas the predicate indication described the usable impression technique of each material. All clinical indications (inlay, onlay, veneer, crown, and bridge preparations as well as fixation and implant impressions) are achievable with the described impression techniques (dual phase and monophase technique). This difference, i.e., stating clinical cases rather than impression techniques, does not raise any new questions regarding safety or effectiveness. Rather, it clarifies the appropriate uses within the described impression techniques and does not expand the indications of the new device(s) beyond those of the predicate device(s).

Technology	Rapid HBRapid LBRapid MB	Impregum Penta Soft Quick Step HBImpregum Penta Soft Quick Step MBImpregum Soft Quick Step LB(K032001)
Light bodied material offered inGarant cartridge system with mixingratio of base and catalyst pastes 2:1(by volume)The pastes are mixed using Garantmixing tips or Intra-oral syringe.	×	×
Medium and Heavy bodied materialoffered in Penta foil bags with mixingratio of base and catalyst paste 5:1(by volume).The pastes are mixed in automaticmixing machine of the Pentamixfamily and Penta mixing tip.	×	×
Material family	Polyethermaterial	Polyether material
Setting characteristic	super quick	quick

Table Comparison to Predicate Technology

Rapid HB, Rapid LB and Rapid MB, Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Imprequm Soft Quick Step LB are Polyether based Precision Impression materials. Chemically they are based on polyalkyleneoxides which cure by a cationic ringopening polymerization mechanism which is initiated by a Sulfonium starter. However, Rapid materials have been developed with the goal to accelerate the curing mechanism by adjusting the initiator system. Additives like fillers, softeners, pigments etc. have been adjusted accordingly.

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Non-clinical testing

In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823. Additionally, the performance of Rapid HB, Rapid LB and Rapid MB was compared to the predicate devices Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB regarding consistency, contact angle, working time, intraoral setting time, recovery from deformation, strain in compression, detail reproduction, compatibility with gypsum type 3 / type 4 and linear dimensional change. The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB. In summary, 3M Deutschland GmbH concludes that Rapid HB, Rapid LB and Rapid MB is substantially equivalent to the predicate devices regarding performance and physical and mechanical properties.

Biocompatibility

The biocompatibility assessment for the products was conducted in accordance with the following guidance:

Guidance	Edition	Title
US FDA DocketNumber FDA-2013-D-0350. CDRHDocument Number1811	June 16,2016	Use of International Standard ISO 10993-1, Biologicalevaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process - Guidance for Industryand Food and Drug Administration Staff
ISO 10993-1	2009	Evaluation and testing within a risk management process
ISO 10993-5	2009	Tests for in vitro cytotoxicity
ISO 10993-10	2010	Tests for irritation and skin sensitization
ISO 10993-11	2006	Tests for systemic toxicity
ISO 10993-12	2012	Sample preparation and reference materials
ISO 10993-18	2005	Chemical characterization of materials
ISO 7405	2008/Amd 1:2013	Evaluation of biocompatibility of medical devices used indentistry

The biocompatibility of Rapid LB, Rapid LB and Rapid MB has been assessed by a boardcertified toxicologist according to recommendations in FDA quidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Rapid HB, Rapid LB and Rapid MB are safe for their intended use.

Conclusion

Comparisons of the indications for use/intended use, composition, technology, and physical and mechanical properties showed that the Rapid HB, Rapid LB and Rapid MB group of materials is as safe, as effective, and performs as well as or better than the legally marketed devices Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB.

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).