LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically. Specifically: Crown restorations: For restoration of the anatomical form in order to provide durable protection for the remaining tooth; In order to restore chewing function; For esthetic corrections. Bridge restorations: In order to restore chewing function; For esthetic corrections.

Device Description

LuxaCrown is a bis-acrylic resin-based self-curing composite for the fabrication of semipermanent crowns and bridges. LuxaCrown is available in a range of shades to ensure an aesthetically-pleasing restoration. LuxaCrown is a non-sterile device intended for use by licensed dental professionals. Because LuxaCrown is intended for the fabrication of semi-permanent dental restorations, it may remain in the oral cavity for more than 30 days. LuxaCrown is supplied in dual-barreled syringes for use with the DMG Automix selfmixing dispenser and Automix Tips, which were previously cleared in K101710 (DMG LuxaTemp Ultra), K013674 (DMG LuxaTemp) and K924830 (DMG LuxaTemp Automix).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental material called LuxaCrown, a self-curing composite for fabricating semi-permanent crowns and bridges. The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical specifications, biocompatibility, and physical properties.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets those criteria in the format requested. The "Discussion of Non-Clinical Tests" section mentions various tests performed (ISO 10447, internal DMG methods, biocompatibility testing) and states that "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." This indicates that there are internal specifications and ISO limits, but the document does not list them as "acceptance criteria" in a table or provide detailed study results that meticulously "prove" the device meets them with specific performance metrics beyond a general statement of compliance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

The document states: "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." However, it does not provide the specific numerical acceptance criteria nor detailed reported performance data in a tabular format. It only lists the types of tests conducted.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the tests mentioned (flexural strength, water sorption, water solubility, working time, setting time, compressive strength, biocompatibility, shelf life).
Data Provenance: The tests were performed by DMG Chemisch-Pharmazeutische Fabrik GmbH, which is a German company (Hamburg, Germany). It's implied these are laboratory tests, not clinical studies with human data, so "retrospective or prospective" is not fully applicable in the conventional sense for patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The tests are for physical and chemical properties of a material, not for diagnostic accuracy or human interpretation requiring expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there's no human interpretation or ground truth establishment in this context.

5. 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 a material science and biocompatibility assessment, not a study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material science assessment.

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

For the physical and chemical tests, the "ground truth" is established by the specified standards (ISO 10447, ISO 10993-3, -5, -10, ASTM F1980) and the manufacturer's internal product specifications. For biocompatibility, it's compliance with established biological safety requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI-based device.

Summary Table (with available information):

Criterion	Details from Document
Acceptance Criteria & Reported Performance	- Acceptance Criteria: "requirements of internal product specifications" and "limits specified in ISO 10477" for physical tests; "requirements of ISO 10993-1:2009 and ISO 7404:2008" for biocompatibility; compliance with ISO 10993-3 (mutagenicity), ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation); ASTM F1980 guidelines for shelf life.
	- Reported Performance: "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." "LuxaCrown was determined to meet all biocompatibility requirements for dental materials." Shelf-life testing "demonstrated that LuxaCrown remains stable over the 2-year product shelf life." Specific numerical values for criteria or performance are not provided in the document.
Sample Size (Test Set)	Not specified.
Data Provenance (Test Set)	Laboratory testing conducted by DMG Chemisch-Pharmazeutische Fabrik GmbH (Germany). Not applicable as retrospective/prospective human data.
Number of Experts for Ground Truth (Test Set)	Not applicable (physical/chemical properties).
Qualifications of Experts	Not applicable.
Adjudication Method (Test Set)	Not applicable.
MRMC Comparative Effectiveness Study	No.
Standalone Performance Study	Yes, implied by the non-clinical tests. However, the performance is against material standards, not diagnostic accuracy.
Type of Ground Truth	Established standards (ISO 10447, ISO 10993, ASTM F1980) and manufacturer's internal product specifications.
Sample Size (Training Set)	Not applicable (not an AI/ML device).
How Ground Truth for Training Set was Established	Not applicable.

In conclusion, while the document confirms that testing was done and met specified requirements, it does not provide the granular detail needed to fill out all aspects of the requested table, particularly the specific numerical acceptance criteria and the detailed reported performance data.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.

May 29, 2019

DMG Chemisch-Pharmazeutische Fabrik GmbH Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K183337

Trade/Device Name: LuxaCrown Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: April 26, 2019 Received: April 30, 2019

Dear Pamela Papineau:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

for Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183337

Device Name

LuxaCrown

Indications for Use (Describe)

LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically.

Specifically:

Crown restorations:

· For restoration of the anatomical form in order to provide durable protection for the remaining tooth
· In order to restore chewing function
· For esthetic corrections
Bridge restorations:
· In order to restore chewing function
· For esthetic corrections

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)

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Summary

K18337

Date Prepared

26 April 2019

510(k) Sponsor

DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 Hamburg 22547 Germany Tel: +49 (0) 40 84006-0 Fax: +49 (0) 40 84006-222 Establishment Registration #8044164

Manufacturer

DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 FDA Establishment Registration Number: 8044164

Contact Person

Pamela Papineau, RAC (US, EU, CAN) Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432, USA Phone: (978) 772-3552 Fax: (978) 391-1391 delphimdc@comcast.net

Subject Device Regulatory Information

Trade Name:	LuxaCrown
Common Name:	Long-term Temporary Crown and Bridge Resin
Product Code:	EBG, POW
FDA Regulation:	21 CFR 872.3770
Device Classification:	Class II

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	Primary PredicateDevice	Reference Device
Trade Name:	Temp Premium, TempPremium Flexible,Multistratum Flexible andTherapon	TempXN28 (currentlymarketed as Protemp Plus)
Manufacturer	Zirkonzahn GmbH	3M ESPE AG
Common Name:	Long-term TemporaryCrown and Bridge Resin	Temporary Crown andBridge Resin
Product Code:	EBG, POW	EBG
FDA Regulation:	21 CFR 872.3770	21 CFR 872.3770
Device Classification:	Class II	Class II
Premarket Notification:	K180562	K073296

Legally Marketed Predicate and Reference Devices

Device Description

LuxaCrown is supplied in dual-barreled syringes for use with the DMG Automix selfmixing dispenser and Automix Tips, which were previously cleared in K101710 (DMG LuxaTemp Ultra), K013674 (DMG LuxaTemp) and K924830 (DMG LuxaTemp Automix).

Indications for Use

LuxaCrown is indicated for use for the fabrication of semi-permanent crowns and bridges The LuxaCrown indications for use statement lists the following examples of specific uses:

Crown restorations:

· For restoration of the anatomical form in order to provide durable protection for the remaining tooth
In order to restore chewing function
· For esthetic corrections

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Bridge restorations:

In order to restore chewing function
· For esthetic corrections

The indications for use statement for the predicate Zirkonzahn products cleared in K 180562 (Temp Premium, Temp Premium Flexible, Multistratum Flexible and Therapon) are very similar:

The resin discs TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.

Differences between the LuxaCrown and the predicate device indications for use, and the justification for each of these differences, are as follows:

1. LuxaCrown is not supplied in the form of resin discs. The "Product Description" section of the LuxaCrown IFU states that LuxaCrown is an automatically mixed, self-curing composite; therefore, it is not necessary to identify the physical form of the product in the indications statement. Also, as demonstrated through testing based on ISO 10447, despite differences in raw materials and physical form, LuxaCrown and the predicate devices are equivalent in terms of physical properties supporting the devices' ability to perform as intended. The 3M ESPE Protemp Plus reference device (K073296) is an example of a legally marketed product with a composition very similar to that of LuxaCrown, with very similar indications for use.
1. The LuxaCrown indications for use do not mention "anterior and posterior" crowns and bridges. This is a wording difference only; by not specifying "anterior and posterior" it is clear that LuxaCrown can be used for both anterior and posterior applications.
The predicate Zirkonzahn TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, 3. MULTISTRATUM FLEXIBLE and THERAPON indications specify a maximum of two adjacent pontics for restorations fabricated with the devices cleared in K180562. The equivalent information is contained in the LuxaCrown instructions for use, which include the following Contraindication: "Do not use this material for bridges with more than two adjacent pontics".
1. The examples of LuxaCrown uses for crowns ("for restoration of the anatomical form in order to provide durable protection for the remaining tooth", "in order to restore chewing function" and "for esthetic corrections") and bridges ("in order to restore chewing function" and "for esthetic corrections") are standard dental

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terminology that apply generally to all crowns and bridges; therefore, these statements do not differ from the general indications statement contained in the predicate device labeling.

1. LuxaCrown refers to the fabrication of "semi-permanent" crowns and bridges; the predicate Zirkonzahn indications specify "a maximum recommended usage time of 12 months". The 3M ESPE ProTemp Plus reference device (K073296) indications refer to the fabrication of "long-lasting temporary" restorations. The terms "semi-permanent" and "long-lasting" have no specific definition in dentistry other than to signal an acceptable period of use beyond the interval ranging from several days to several weeks typically indicated by the descriptor "short-term", or even by the word "temporary" alone. DMG has provided test data collected in a chewing simulator to demonstrate that crowns made from LuxaTemp survive cyclic loading for the equivalent of > 5 years. Therefore, this difference in terminology is supported by laboratory testing.

Discussion of Non-Clinical Tests

LuxaCrown was tested in accordance with ISO 10447:2004 to determine physical characteristics such as flexural strength, water sorption and water solubility. Internal DMG test methods were used to test other characteristics not addressed in ISO 10477 (working time, setting time, compressive strength). The results of these tests were compared to the DMG product specification for LuxaCrown, and to data for the primary predicate and reference devices. All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477.

A biocompatibility assessment documented for LuxaCrown established that the product meets the requirements of ISO 10993-1:2009 and ISO 7404:2008 with respect to biocompatibility. The LuxaTemp biocompatibility assessment was supported by biocompatibility testing conducted in accordance with ISO 10993-3 (mutagenicity), ISO 10993-5 cytotoxicity) and ISO 10993-10 (sensitization/irritation). LuxaCrown was determined to meet all biocompatibility requirements for dental materials.

Testing was performed to support the 2-year shelf life of LuxaCrown using device samples that were aged in accordance with the guidelines described in ASTM F1980. Physical properties (working time, setting time, flexural strength, compressive strength, fracture toughness, polymerization shrinkage, smear layer and peak polymerization temperature) of the aged samples were measured to confirm that the device continues to meet specifications with no significant degradation in physical properties at the end of the labeled shelf life. This testing demonstrated that LuxaCrown remains stable over the 2year product shelf life.

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Conclusion

Based on a comparison of the device indications for use, technical specifications, biocompatibility and physical properties, LuxaCrown has been shown to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.