Use of Suglue 3 in Adhesive Mode with ADH19
·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges
·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops)

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges

·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws

·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Device Description

Suglue 3 is a dual-curing universal cement that is used for both adhesive and self-adhesive cementation of indirect restorations and posts, whereas RelyX Unicem 2 Automix is a selfadhesive cement and RelyX Ultimate is an adhesive cement. New redox initiator system provides improved bond strength to tooth structure, especially dentin. Changed characteristics allow easier excess removal. Increased radioopacity facilitates clinicians to see the Suglue 3 in radiographs as well as tooth like fluorescence for an esthetic appearance, especially in the anterior region. Suglue 3 is used in combination with ADH19 (dental adhesive, product of 3M Deutschland GmbH) for adhesive cementation. ADH19 adhesive is self-etching. Optionally, the adhesive strength can be enhanced further through additional etching of the tooth structure with Scotchbond Universal Etchant (product of 3M Deutschland GmbH). Standard cases as well as post cementations can be solved securely and efficiently when Suglue 3 is used in selfadhesive mode.

AI/ML Overview

The provided FDA 510(k) document details the clearance of a dental cement, Suglue 3. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, composition, technology, and various physical and mechanical properties.

Crucially, this document does not describe acceptance criteria, a study proving device performance against such criteria in the context of an AI/ML device, or any of the specific AI/ML related questions posed (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

The document is for a medical device (dental cement) and does not involve AI or machine learning. Therefore, the requested information regarding AI/ML device performance and study design elements cannot be extracted from this text.

The information from the document related to general device performance studies is as follows:

A table of acceptance criteria and the reported device performance:
- The document does not provide a table of explicit acceptance criteria with specific thresholds for each performance metric. It rather states that "The results of Suglue 3 are comparable to RelyX Unicem 2 Automix, and RelyX Ultimate."
- Reported performance (in comparison to predicate devices):
  - Excess removal forces (comparable)
  - Pull-out bond strength to endodontic post (comparable)
  - Shear bond strength to tooth structure (dentin and enamel), glass ceramic (feldspathic and lithium disilicate ceramics), zirconia, metals (gold, remanium, and titanium), and composites (comparable)
  - Film thickness (comparable)
  - Working time (comparable)
  - Flexural strength (comparable)
  - Water sorption (comparable)
  - Solubility (comparable)
  - Shade (comparable)
  - Color stability (comparable)
  - Radioopacity (comparable)
  - Compressive strength (comparable)
Sample size used for the test set and the data provenance:
- Not applicable as this is a physical dental cement, not an AI/ML device using a test set of data. The document does not specify sample sizes for the in vitro tests conducted.
- Data provenance is not mentioned beyond the tests being "in vitro."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here would refer to the measured physical and mechanical properties of the cement, established through standardized laboratory testing, not by expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human expert review of clinical data, not to physical property testing of a dental cement.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is for an AI/ML device, which Suglue 3 is not.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for an AI/ML device, which Suglue 3 is not.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and mechanical properties of the dental cement, the "ground truth" is established through direct measurement and testing methods, some of which are based on ISO standards (e.g., ISO 4049:2009, ISO 9917-1:2008).
The sample size for the training set:
- Not applicable. There is no AI/ML model to train for this device.
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML model to train for this device.

Summary

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Image /page/0/Picture/0 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.

November 5, 2019

3M Deutschland GMBH % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192992

Trade/Device Name: Suglue 3 Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA Dated: October 24, 2019 Received: October 25, 2019

Dear Prithul Bom:

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 mediation-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.

for 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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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) K192992

Device Name Suglue 3

Indications for Use (Describe)

Use of Suglue 3 in Adhesive Mode with ADH19 ·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges ·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops)

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges

·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws

·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

Page 1 of 1

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3M Deutschland GmbH

Carl-Schurz-Straße 1 41453 Neuss

Establishment Registration Number: 9611385

Postal Address: ESPE Platz 82229 Seefeld Germany

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

|--|

510(k) Summary Submitter:.................................................................................................................................................................... ESPE Platz 82229 Seefeld Germany

K192992

Contact Person	Dr. Desi W. Soegiarto
	Manager Regulatory Medical Devices
	Phone: +49-8152-700 1169
	Fax: +49-8152-700 1869
	e-mail: ruediger.franke@3M.com
Date:	September 6, 2019

Trade Name: ................................................................................................. Suglue 3

Common Name: ................................................................................................................................................................

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

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

Primary Predicate Device ......... RelyX Unicem 2 Automix (K100756) Reference Predicate Device ..... RelyX Ultimate (K110508)

Description of Device

Sitz: 41453 Neuss · Handelsregister: B 1878 Amtsgericht Neuss Geschäftsführer: Christiane Grün, Manfred Hinz, Oliver Leick Vorsitzende der Geschäftsführung: Christiane Grün; Vorsitzender des Aufsichtsrates: Günter Gressler

Image /page/3/Picture/16 description: The image shows a logo for "Deutsche Dental Industrie". The logo consists of a stylized letter "D" formed by concentric circles, with a small triangle cut out of the bottom right of the letter. To the right of the circular "D" is the text "Deutsche Dental Industrie" stacked vertically.

3M Deutschland GmbH

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Applicable Standards for Product Tests

No ISO standard for performance testing applies to the resin cement Suglue 3. However, some in vitro data were obtained using methods described in ISO standards for other cement classes (e.g. ISO 4049:2009, ISO 9917-1:2008).

Indications for Use of Suglue 3

Use of Suglue 3 in Adhesive Mode with ADH19

Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges -
Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops) -

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

-Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges
Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws
Final cementation of all-ceramic, composite, or metal restorations on implant abutments -

Comparison

Suglue 3 was compared to RelyX Unicem 2 Automix and RelyX Ultimate regarding indications for use, intended use, composition, technology, and physical and mechanical properties. The tables below summarize the indications and technology of Suglue 3 and predicate devices:

Device	Suglue 3	RelyX Unicem 2Automix (K100756)	RelyX Ultimate(K110508)
Intended Use
Dental luting agent forcementation of indirectrestorations	×	×	×
Indications for Use
	Use of Suglue 3in Adhesive Modewith ADH19		UsingScotchbondUniversaladhesive
Final cementation ofall-ceramic or metalMaryland bridges and3-unit inlay/onlaybridges	×	×	×
Final cementation ofall-ceramic orcomposite veneers andocclusal veneers(tabletops)	×	-	×
	Use of Suglue 3in Adhesive Modewith ADH19 or inSelf-AdhesiveMode		UsingScotchbondUniversaladhesive

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Final cementation ofall-ceramic, composite,or metal inlays andonlays, crowns, andbridges	X	X	X
Final cementation ofposts made of ceramic,glass fiber-reinforcedcomposite or metal,and screws	X	X	X
Final cementation ofall-ceramic, composite,or metal restorations onimplant abutments	X	X	X

Table Comparison of indications

Device	Suglue 3	RelyX Unicem 2Automix (K100756)	RelyX Ultimate(K110508)
Technology
Dual-cure resin cement	X	X	X
Consists of base pasteand catalyst paste	X	X	X
Composition:Monomers, fillers,Initiators, stabilizers,pigments	X	X	X
Supplied in Automixsyringe and applied viamixing tips	X	X	X

Table Comparison of technology

Suglue 3, RelyX Unicem 2 Automix, and RelyX Ultimate are dental dual-cure resin cements consist of two components (base paste and catalyst paste) containing monomers, fillers, initiators, stabilizers, and pigments. Base paste and catalyst paste of the cements are supplied in automix syringes and applied via mixing tips. 3M Deutschland GmbH is providing information to FDA about the composition of Suglue 3 and compared this to the predicate devices.

In vitro testing was conducted to show the performance of Suglue 3 and compared to the predicate devices RelyX Unicem 2 Automix and RelyX Ultimare regarding excess removal forces, pull-out bond strength to endodontic post, shear bond strength to tooth structure (dentin and enamel), glass ceramic (feldspathic and lithium disilicate ceramics), zirconia, metals (qold, remanium, and titanium), and composites. Tests on Suglue 3, RelyX Unicem 2 Automix, and RelyX Ultimate were performed for film thickness, working time, flexural strength, water sorption, solubility, shade, color stability, radioopacity, and compressive strength. The results of Suglue 3 are comparable to RelyX Unicem 2 Automix, and RelyX Ultimate. In summary, 3M Deutschland GmbH concludes that Suglue 3 is substantially equivalent to the predicate devices regarding performance and physical and mechanical properties.

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Biocompatibility

The biocompatibility assessment for the product was conducted in accordance with the following quidance:

Guidance	Edition	Title
US FDA DocketNumber FDA-2013-D-0350.CDRH DocumentNumber 1811	June 16, 2016	Use of International Standard ISO 10993-1, Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process - Guidancefor Industry and Food and Drug Administration Staff
ISO 10993-1	2018	Evaluation and testing within a risk managementprocess
ISO 10993-3	2014	Tests for genotoxicity, carcinogenicity andreproductive toxicity
ISO 10993-5	2009	Tests for in vitro cytotoxicity
ISO 10993-6	2016	Tests for local effects after implantation
ISO 10993-10	2010	Tests for irritation and skin sensitization
ISO 10993-11	2017	Tests for systemic toxicity
ISO 10993-12	2012	Sample preparation and reference materials
ISO 10993-18	2005	Chemical characterization of materials
ISO/TR 10993-22	2017	Guidance on nanomaterials
ISO 7405	2018	Evaluation of biocompatibility of medical devices usedin dentistry

Table Guidances for biocompatibility assessment

The biocompatibility of Suglue 3 has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Suglue 3 is safe for its intended use.

Conclusion

Comparisons of the intended use, indications for use, composition, technology, and physical and mechanical properties showed that Suglue 3 does not raise any new questions about safety and effectiveness and is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.