(11 days)
No
The device description and performance studies focus on the material properties and clinical performance of a dental cement, with no mention of AI or ML technology.
No
This device is a dental cement used for the final cementation of various indirect dental restorations, which is a structural and restorative function, not a therapeutic one.
No.
Suglue 3 is a dental cement used for the final cementation of restorations and posts, a therapeutic rather than diagnostic function.
No
The device description clearly states that Suglue 3 is a "dual-curing universal cement," which is a physical material, not software. The summary describes its chemical and physical properties and its use in combination with other physical dental materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental cement for the final cementation of various dental restorations (bridges, veneers, inlays, onlays, crowns, posts, restorations on implant abutments). This is a direct application within the body (or on structures within the body like teeth), not for testing samples taken from the body.
- Device Description: The description focuses on the chemical and physical properties of the cement and its use in bonding dental materials to tooth structure.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
The device is a dental material used for restorative procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
EMA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RelyX Unicem 2 Automix (K100756)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
RelyX Ultimate (K110508)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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 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
2
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.
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:
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Food and Drug Administration
Office of Chief Information Officer
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"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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
==============================================================================================================================================================================
3
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
| 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
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.
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
4
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 2
Automix (K100756) | RelyX Ultimate
(K110508) |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------|
| Intended Use | | | |
| Dental luting agent for
cementation of indirect
restorations | × | × | × |
| Indications for Use | | | |
| | Use of Suglue 3
in Adhesive Mode
with ADH19 | | Using
Scotchbond
Universal
adhesive |
| 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 | | Using
Scotchbond
Universal
adhesive |
5
| Final cementation of
all-ceramic, composite,
or metal inlays and
onlays, crowns, and
| bridges | X | X | X |
|---|---|---|---|
| Final cementation of | |||
| posts made of ceramic, | |||
| glass fiber-reinforced | |||
| composite or metal, | |||
| and screws | X | X | X |
| Final cementation of | |||
| all-ceramic, composite, | |||
| or metal restorations on | |||
| implant abutments | X | X | X |
Table Comparison of indications
| Device | Suglue 3 | RelyX Unicem 2
Automix (K100756) | RelyX Ultimate
(K110508) |
|----------------------------------------------------------------------------|----------|-------------------------------------|-----------------------------|
| Technology | | | |
| Dual-cure resin cement | X | X | X |
| Consists of base paste
and catalyst paste | X | X | X |
| Composition:
Monomers, fillers,
Initiators, stabilizers,
pigments | X | X | X |
| Supplied in Automix
syringe and applied via
mixing 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.
6
Biocompatibility
The biocompatibility assessment for the product was conducted in accordance with the following quidance:
| Guidance | Edition | Title |
|---|---|---|
| US FDA Docket | ||
| Number FDA- | ||
| 2013-D-0350. | ||
| CDRH Document | ||
| Number 1811 | June 16, 2016 | Use of International Standard ISO 10993-1, Biological |
| evaluation of medical devices - Part 1: Evaluation and | ||
| testing within a risk management process - Guidance | ||
| for Industry and Food and Drug Administration Staff | ||
| ISO 10993-1 | 2018 | Evaluation and testing within a risk management |
| process | ||
| ISO 10993-3 | 2014 | Tests for genotoxicity, carcinogenicity and |
| reproductive 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 used |
| in 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.