P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.
It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.
Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.

AI/ML Overview

The provided text is a 510(k) Summary for a dental device called "P pro Crown & Bridge." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the chemical, physical, and biocompatibility properties of the material rather than a "device" in the sense of an AI or diagnostic tool that would typically involve a multi-reader, multi-case study or extensive clinical performance data with ground truth experts.

Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC, human reader improvement, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning its physical, mechanical, and biocompatibility properties.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for "P pro Crown & Bridge" are primarily based on established ISO standards for dental materials (ISO 4049 and ISO 10477) and an internal DeltaMed standard for compressive strength. The device performance is then compared directly against these criteria and its predicate devices.

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

Property / Requirement	Acceptance Criteria	Reported Device Performance (P pro Crown & Bridge)	Passes/Fails
Mechanical Properties (ISO 4049 & ISO 10477)
Flexural strength (ISO 4049)	≥ 100 MPa	146 MPa	Pass
Flexural strength (ISO 10477)	≥ 50 MPa	146 MPa	Pass
Solubility (ISO 4049 & ISO 10477)	≤ 7.5 µg/mm³	0.5 µg/mm³	Pass
Water absorption (ISO 4049 & ISO 10477)	≤ 40 µg/mm³	16 µg/mm³	Pass
Color stability (ISO 4049 & ISO 10477)	Not explicitly quantified, "pass"	Pass	Pass
Mechanical Properties (DeltaMed internal standard)
Compressive Strength	> 300 MPa	358 MPa	Pass
Modulus of elasticity	> 5000 MPa	5988 MPa	Pass

Biocompatibility (ISO 10993-1, -5, -10):

Biocompatibility Test	Acceptance Criteria (Implied: "Pass")	Reported Device Performance (P pro Crown & Bridge)	Passes/Fails
Cytotoxicity (ISO 10993-5)	Compliant	Performed and substantiated safety	Pass
Sensitization (ISO 10993-10)	Compliant	Performed and substantiated safety	Pass
Irritation (ISO 10993-10)	Compliant	Performed and substantiated safety	Pass

Study Details (as inferable from the document):

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated in terms of the number of individual specimens tested for each property (e.g., how many samples for flexural strength). However, the results (e.g., "146 MPa") imply a quantitative measurement from a test set.
Data provenance:
- Country of origin: The manufacturer, DeltaMed GmbH, is based in Friedberg, Germany. The testing would presumably be conducted in Germany or by certified labs adhering to international standards.
- Retrospective or Prospective: These are laboratory tests on material samples, not clinical studies involving patient data. Therefore, "retrospective" or "prospective" as typically applied to clinical data collection does not directly apply. The tests are conducted on manufactured material samples to demonstrate performance against specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological testing standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). The "truth" is the measured property value compared to the standard's requirement, not an expert's interpretation of an image or clinical finding. These tests are performed by qualified laboratory technicians/scientists following validated protocols.

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

Not Applicable. Adjudication methods are relevant for subjective assessments (e.g., consensus among radiologists). For objective material properties testing, results are quantitative and directly measured. Statistical analysis of multiple measurements would be performed to ensure reliability, but not "adjudication."

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 device, not a diagnostic imaging device or AI software. There are no "human readers" or "AI assistance" in this context.

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

Not Applicable. This is a material device.

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

Objective Laboratory Measurements against International Standards: The "ground truth" is derived from standardized laboratory testing procedures (e.g., measuring flexural strength, water absorption, cytotoxicity) as defined by ISO standards (ISO 4049, ISO 10477, ISO 10993). The "truth" is whether the measured physical/chemical property falls within the acceptable range specified by these standards.

8. The sample size for the training set:

Not Applicable. This device is a material, not an AI/machine learning algorithm that requires a "training set." The characteristics of the material are inherent to its composition and manufacturing process, not learned from data. Extensive R&D and formulation development would have occurred, but not in the sense of "training data."

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

Not Applicable. No "training set" as defined for AI/ML. The properties of the material (composition, etc.) are determined during the material science and engineering development process.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

July 31, 2020

DeltaMed GmbH % Gary Chuven Director of Regulatory Affairs Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, Illinois 60611

Re: K200039

Trade/Device Name: P pro Crown & Bridge Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: June 22, 2020 Received: July 6, 2020

Dear Gary Chuven:

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/cfpmp/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/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 (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 "Nandu" Nandkumar, Ph.D. 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

510(k) Number (if known) K200039

Device Name P pro Crown & Bridge

Indications for Use (Describe)

Additive production of temporary anterior and posterior restorations, e.g.

Single tooth crowns.
Bridges (max. six units, max. two consecutive pontics).
Veneers, Inlays, Onlays.

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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Section 5: 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c)

510(k) No.:	K200039
Date Prepared:	2020-07-29
501(k) Submitter:	DeltaMed GmbHRaiffeisenstr. 8a61169 FriedbergDeutschland / GermanyTel. +49 (0) 6031 / 7283- 0Fax. +49 (0) 6031 / 7283- 29E-mail: info@deltamed.de
Contact Person:	Michael ZimmermannRegulatory AffairsDeltaMed GmbHTel: +49 (0) 6031 / 7283- 17Email: michael.zimmermann@deltamed.de
Trade Names:	P pro Crown & Bridge
Common Name:	Crown and bridge, temporary, resin
Regulatory Class:	Class II
Device Panel:	Dental Panel
Regulation Number:	21 CFR 872.3770
Classification Name:	Temporary crown and bridge resin
Product Code:	EBG

Predicate Devices:

(1) Primary Predicate e-Dent Temporary; DeltaMed GmbH, Friedberg, DE

(2) Predicate Device Vita CAD-Temp for in Lab: VITA Zahnfabrik GmbH & Co KG, Säckingen, GE
(3) Predicate Device Luxatemp Ultra/Luxatemp Star: DMG Inc., Ayer Ma. USA

Description of Device:

P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.

It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.

Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.

Intended Use:

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P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.

Indications for Use:

Additive production of temporary anterior and posterior restorations, e.g.
Single-tooth crowns.
Bridges (max. six units, max. two consecutive pontics).
Veneers, inlays, onlays.

Biocompatibility testing

The biocompatibility evaluation for P pro Crown & Bridge was conducted in accordance with the Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the International Standard ISO 10993-1:2018(R) 2019 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity (ISO 10993-5) i
Sensitization (ISO 10993-10)
Irritation (ISO 10993-10)

According to ISO 10993-2 "Biological evaluation of medical devices ----------------------------------------------------------------------------------------------------------no additional animal testing were necessary to ensure human safety. For the evaluation of the biological risk of endpoints: systemic- and CMR toxicity, sufficient literature data were available.

Substantial Equivalence Discussion:

Subject Device	: P pro Crown & Bridge
(1) Primary Predicate Device	: e-Dent Temporary
(2) Predicate Device	: Vita CAD-Temp, for in Lab
(3) Predicate Device	: Luxatemp Ultra / Luxatemp Sta

Submission:	Class. Name:	Product Code	Regulation No.
(1) K102776	Crown and Bridge, Temporary, Resin	EBG	872.3770
(2) K070991	Crown and Bridge, Temporary, Resin	EBG	872.3770
(3) K101710	Crown and Bridge, Temporary, Resin	EBG	872.3770

The table on the following page compares the subject device with its predicates:

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Property	Subject Device	(1) Primary Predicate	(2) Predicate Device	(3) Predicate Device
	P pro Crown &Bridge	e-Dent Temporary(K102776)	Vita CAD-Temp forinLab (K070991)	Luxatemp Ultra /Star(K101710)
Intended use,Indications	Additive productionof temporary anteriorand posteriorrestorations, e.g.Single-tooth crowns.Bridges (max. sixunits, max. twoconsecutive pontics).Veneers, inlays,onlays.	e-dent Temp is used forthe fabrication of multi-unit, fully or partiallyanatomical long-termtemporary crown andbridge restorations,anterior crowns.posterior crowns,anterior/posteriorbridges 3 or 4 units, 1pontic	CAD-Temp is usedfor the fabrication ofmulti-unit, full orpartial anatomicallong term temporarybridge restorationswith up to 2 ponticsusing the inLab orCEREC systems ofSirona. The bridgeblock can also beused for temporarycrowns.	Self-curing compositefor the fabrication oftemporary crowns andbridges, inlays, onlaysand veneers.
Processing	Additivemanufacturing, usingprinters with 385 nmwavelength	Additive manufacturingusing Perfactory DDP,350-420nm; (DentalDigital Printer),Envisiontec GmbH,Germany	Substractive(mechanical)processing	Self-curing composite
Requirements1. ISO 40492. ISO 10477		Mechanical Properties according to ISO 4049 and ISO 10477
Flexural strength	146 MPa	123 MPa	> 80 MPa	125 MPa
1. ≥ 100 MPa	pass	pass	./.	pass
2. ≥ 50 MPa	pass	pass	pass	pass
Solubility	0.5 µg/mm3	0 µg/mm3	No data	No data
1. & 2.≤ 7,5 µg/mm3	pass	pass	Complies withISO 10477	---
Water absorption	16 µg/mm3	18 µg/mm3	No data	10 µg/mm3
1. & 2.≤ 40 µg/mm3	pass	pass	Complies withISO 10477	pass
Color stability1. & 2.	pass	pass	Complies	No data
Requirements	Mechanical Properties according to DeltaMed internal standard
CompressiveStrength (MPa)	358 MPa	354 MPa	n.e.	376 MPa
> 300 MPa	pass	pass	---	pass

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Property	Subject Device	(1) Primary Predicate	(2) Predicate Device	(3) Predicate Device
	P pro Crown &Bridge	e-Dent Temporary(K102776)	Vita CAD-Temp forinLab (K070991)	Luxatemp Ultra /Star(K101710)
Modulus ofelasticity	5988 MPa	5300 MPa	>2800 MPa	No data
> 5000 MPa	pass	pass	./.	---
Composition/Chemical properties
Acrylate monomers with initiators,stabilizers and pigments, approx. 50%inorganic fillers		Modifiedpolymethacrylates with14% inorganic filler	Matrix of multi-functionalmethacrylates;catalysts, stabilizersand additives

Discussion:

Primary Predicate Device: All four products have substantially the same intended use as temporary esthetic (dental) restorative materials but differ in the indication for use. The predicate device (1) as the primary predicate device is used to demonstrate substantially equivalence in manufacturing method, indication (fully or partially anatomical long-term temporary crown and bridge -but limited by 4 units and 1 ponic), chemical- and biological properties.

(2) Reference Device: Is referenced based on its physical properties to demonstrate equivalence of the expanded indication of 2 pontics.

(3) Predicate Device: Concerning the additional claims (indications) "veneers, inlays, onlays", was selected to show the equivalence with the subject device.

The physical, mechanical and chemical properties of the subject device, the primary predicate device (K102776) and the two predicate devices (K070991 and K101710) are very similar. Although the indication refers to temporary restoration, the subject device complies with the standards ISO 4049 (Polymer-based restorative materials) and ISO 10477 (Polymer-based crown and veneering materials) in terms of flexural strength, water sorption, solubility and color stability.

Biocompatibility studies were performed on the subjected device. The data were analyzed and the results of the biocompatibility test (10993-xx) substantiate that P pro Crown & Bridge with its modification in composition is as safe (biocompatible) as the primary predicate.

Results/summary of the Substantial Equivalence

The subject device P pro Crown & Bridge has been compared with its primary predicate device e-Dent Temporary (K102776) and the two predicate devices- Vita CAD-Temp for inLab (K070991) and Luxatemp Ultra / Star (K101710), with regard to indication (intended use), performance data, chemical composition and biocompatibility.

It can be concluded, that the subject device P pro Crown & Bridge is substantially equivalent to the predicates.

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.