Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental material for additive manufacturing and its physical/chemical properties, with no mention of AI or ML.

Therapeutic

No
The device is a material used for the additive production of temporary dental restorations, serving a structural and palliative role, rather than directly treating a disease or condition.

Diagnostic

No

The device is a material for manufacturing temporary dental restorations and not for diagnosing any condition. Its intended use and a description of the device clearly state its purpose as a restorative material.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "flowable, light-curing, acrylate-based composite material" and details its physical composition and properties. This indicates it is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that this device is a material for the "additive production of temporary anterior and posterior restorations" (dental). This involves creating physical structures that are placed in the body, not analyzing samples from the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The performance studies focus on material properties and biocompatibility, which are relevant to a medical device intended for implantation or contact with the body, but not for in vitro diagnosis.

Therefore, this device falls under the category of a medical device, specifically a dental material, rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EBG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior and posterior restorations (dental)

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural strength: 146 MPa (Passes >= 100 MPa for ISO 4049, >= 50 MPa for ISO 10477)
Solubility: 0.5 µg/mm3 (Passes 300 MPa for DeltaMed internal standard)
Modulus of elasticity: 5988 MPa (Passes > 5000 MPa for DeltaMed internal standard)

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.

K102776, K070991, K101710

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.

Not Found

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

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.

Summary

0

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

1

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

2

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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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)

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

3

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 GmbH
Raiffeisenstr. 8a
61169 Friedberg
Deutschland / Germany
Tel. +49 (0) 6031 / 7283- 0
Fax. +49 (0) 6031 / 7283- 29
E-mail: info@deltamed.de
Contact Person:	Michael Zimmermann
Regulatory Affairs
DeltaMed GmbH
Tel: +49 (0) 6031 / 7283- 17
Email: 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:

4

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:

5

Property	Subject Device	(1) Primary Predicate	(2) Predicate Device	(3) Predicate Device
	P pro Crown &
Bridge	e-Dent Temporary
(K102776)	Vita CAD-Temp for
inLab (K070991)	Luxatemp Ultra /
Star
(K101710)
Intended use,
Indications	Additive production
of temporary anterior
and posterior
restorations, e.g.
Single-tooth crowns.
Bridges (max. six
units, max. two
consecutive pontics).
Veneers, inlays,
onlays.	e-dent Temp is used for
the fabrication of multi-
unit, fully or partially
anatomical long-term
temporary crown and
bridge restorations,
anterior crowns.
posterior crowns,
anterior/posterior
bridges 3 or 4 units, 1
pontic	CAD-Temp is used
for the fabrication of
multi-unit, full or
partial anatomical
long term temporary
bridge restorations
with up to 2 pontics
using the inLab or
CEREC systems of
Sirona. The bridge
block can also be
used for temporary
crowns.	Self-curing composite
for the fabrication of
temporary crowns and
bridges, inlays, onlays
and veneers.
Processing	Additive
manufacturing, using
printers with 385 nm
wavelength	Additive manufacturing
using Perfactory DDP,
350-420nm; (Dental
Digital Printer),
Envisiontec GmbH,
Germany	Substractive
(mechanical)
processing	Self-curing composite
Requirements

ISO 4049
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 with
ISO 10477 | --- |
| Water absorption | 16 µg/mm3 | 18 µg/mm3 | No data | 10 µg/mm3 |
| 1. & 2.
≤ 40 µg/mm3 | pass | pass | Complies with
ISO 10477 | pass |
| Color stability
& 2. | pass | pass | Complies | No data |
| Requirements | Mechanical Properties according to DeltaMed internal standard | | | |
| Compressive
Strength (MPa) | 358 MPa | 354 MPa | n.e. | 376 MPa |
| > 300 MPa | pass | pass | --- | pass |

6

Property	Subject Device	(1) Primary Predicate	(2) Predicate Device	(3) Predicate Device
	P pro Crown &
Bridge	e-Dent Temporary
(K102776)	Vita CAD-Temp for
inLab (K070991)	Luxatemp Ultra /
Star
(K101710)
Modulus of
elasticity	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		Modified
polymethacrylates with
14% inorganic filler	Matrix of multi-
functional
methacrylates;
catalysts, stabilizers
and 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.