(115 days)
Not Found
No
The device description and performance studies focus on the material properties and application of dental ceramics, with no mention of AI or ML.
No.
The device is a system of dental veneering ceramics used for the aesthetic individualization of dental crowns and bridges, which is not considered a therapeutic function.
No
Explanation: The device is described as veneering ceramics used for esthetic individualization of dental crowns and bridges. Its intended use is to color, texture, and glaze these dental restorations, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a dental ceramic material in paste and liquid form, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions." This describes a material used on a dental restoration, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details dental ceramics used for coloring, texturing, and glazing dental restorations. This is a material applied externally to a device that is placed in the body, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Classification: The device is classified as Type I, Class 1b) according to ISO 6872, which is a standard for dental ceramic materials, not IVDs.
- Testing: The non-clinical testing focuses on biocompatibility and material properties (flexural strength), which are relevant for dental materials, not diagnostic performance metrics like sensitivity or specificity.
In summary, the DD contrast® veneering ceramics system is a dental material used for aesthetic purposes on dental restorations, not a diagnostic device.
N/A
Intended Use / Indications for Use
The DD contrast® veneering ceramics system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
DD contrast veneering ceramics are dental ceramics for the esthetic individualization of crowns and bridges made from zirconia or lithium disilicate. The DD contrast group consists of various ceramic veneering pastes (already pre-mixed) for coloring, texturing and glazing as well as liquids for adjusting the textures of the paste variants.
The DD contrast products are applied to the sintered zirconium dioxide or lithium disilicate restoration and fired in a standard furnace for veneering ceramics.
Due to the different consistencies, the pastes can be used to achieve thin shade and glaze layers as well as structure-building areas on the crowns.
The veneering ceramics are of type I, class 1b) according to ISO 6872 (FDA Recognition Number 4-251).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental crown and bridge constructions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
knowledgeable and trained dental personnel
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)
Clinical Tests
Dental Direkt GmbH did not conduct, nor rely upon, clinical tests to determine substantial equivalence as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US.
Non-Clinical Tests
Non-clinical testing was performed in order to validate the product against the company's specified design requirements according to the following standards:
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA Recognition #4-212) ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (FDA Recognition #2-258)
The DD contrast products are proven to be biocompatible. ISO 6872, Dentistry - Ceramic materials (FDA Recognition #4-251)
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.
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
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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April 16, 2020
Dental Direkt GmbH Patrick Berz Regulatory Affairs Manager Industriezentrum 106-108 Spenge, 32139 Germany
Re: K193588
Trade/Device Name: DD Contrast Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 15, 2020 Received: January 17, 2020
Dear Patrick Berz:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 "Nandu" Nandkumar, PhD Director DHT1B: Division of Dental Devices 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name DD Contrast
Indications for Use (Describe)
The DD contrast® veneering ceramics system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
| 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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Image /page/3/Picture/1 description: The image contains the logo for Dental Direkt. The logo consists of a stylized cross made up of gray and dark gray squares, with one orange square in the center. To the right of the cross are the words "Dental" in light gray and "Direkt" in dark gray, stacked on top of each other.
Dental Direkt GmbH I Industriezentrum 106 – 108 I D-32139 Spenge
510(k) Summary
| Submitter of 510(k) | Dental Direkt GmbH
Industriezentrum 106-108
32139 Spenge / Germany |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mr. Uwe Greitens, CEO
Phone:+49 5225 86319-0
Fax: +49 5225 86319-99
u.greitens@dentaldirekt.de |
| Regulatory Correspondent | Mr. Patrick Berz, Manager Regulatory Affairs
Phone:+49 5225 86319-0
Fax: +49 5225 86319-99
p.berz@dentaldirekt.de |
| Establishment Registration No. | 3008347275 |
| Date Prepared | 2020/04/16 |
| Trade Name of Device | DD contrast |
| Common Name | Powder, Porcelain |
| Classification Name | Porcelain Powder for clinical use |
| Product Code | EIH |
| Regulation Number | 21 CFR 872.6660 |
| Classification | Class II |
| 510(k) Number | K193588 |
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| Primary Predicate Device | K111743: Jensen Industries:
InSync Ceramic System (Model name: "MiYO – liquid
ceramic") |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The DD contrast® veneering ceramics system is
suitable for the esthetic individualization of monolithic
or minimally reduced dental crown and bridge
constructions made of zirconium dioxide or lithium
disilicate. |
| Device Description | DD contrast veneering ceramics are dental ceramics
for the esthetic individualization of crowns and
bridges made from zirconia or lithium disilicate. The
DD contrast group consists of various ceramic
veneering pastes (already pre-mixed) for coloring,
texturing and glazing as well as liquids for adjusting
the textures of the paste variants.
The DD contrast products are applied to the sintered
zirconium dioxide or lithium disilicate restoration and
fired in a standard furnace for veneering ceramics.
Due to the different consistencies, the pastes can be
used to achieve thin shade and glaze layers as well
as structure-building areas on the crowns.
The veneering ceramics are of type I, class 1b)
according to ISO 6872 (FDA Recognition Number 4-
251). |
| Technological Characteristics | The technological characteristics of the new product
are the same as those of the legally marketed device.
Both products are feldspar ceramics fired onto a
dental ceramic framework made of zirconium dioxide
or lithium disilicate. With this veneering technique it is
possible to design a crown or bridge to individual
patient requirements. |
| Material composition | Feldspar ceramics, main components: SiO2, Al2O3,
B2O3, K2O, Na2O |
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| Discussion of
Tests Performed | Clinical Tests
Dental Direkt GmbH did not conduct, nor rely upon, clinical tests to determine substantial equivalence as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US.
Non-Clinical Tests
Non-clinical testing was performed in order to validate the product against the company's specified design requirements according to the following standards:
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA Recognition #4-212) ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (FDA Recognition #2-258) The DD contrast products are proven to be biocompatible. ISO 6872, Dentistry - Ceramic materials (FDA Recognition #4-251) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substancial
Equivalence | Material
The composition of DD contrast corresponds to that of the predicate device.
Physical Properties |
DD contrast has physical properties comparable to those of predicates.
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Technical comparison
| Feature | Predicate Device | New Device |
|---|---|---|
| Trade name | InSync Ceramic System | DD contrast |
| Model name | MiYO Esthetic System Kit | DD contrast |
| Indications | ||
| Indications for Use | ||
| Statement | "InSync Ceramic System": | |
| The pressable ceramic | ||
| pellets are pressed onto | ||
| zirconia frames by dental | ||
| technicians to fabricate full | ||
| ceramic crowns and the | ||
| ceramic layering porcelain | ||
| and liquids are used to | ||
| build up the pressed | ||
| ceramic to final tooth | ||
| morphology and shade. | ||
| The ceramic layering | ||
| porcelain and liquids are | ||
| also used in building | ||
| ceramic crowns and | ||
| bridges on titanium and | ||
| titanium alloy substructures. | ||
| Both applications are to | ||
| provise protheses for | ||
| missing / damaged teeth. | ||
| "MiYO Esthetic System Kit": | ||
| A Type 1, class 1b ceramic | ||
| for the coloring, enhancing, | ||
| and glazing of the following | ||
| restoration types: Zirconia | ||
| and Lithium Disilicate. | The DD contrast® | |
| veneering ceramics | ||
| system is suitable for the | ||
| esthetic individualization of | ||
| monolithic or minimally | ||
| reduced dental crown and | ||
| bridge constructions made | ||
| of zirconium dioxide or | ||
| lithium disilicate. | ||
| Comment on Indications for Use Statement: | ||
| The indication of the predicate ("InSync Ceramic | ||
| System") is comparable to that of the new device, even if | ||
| it is written in a very general way and includes different | ||
| veneering ceramics. The relevant parts of the indication | ||
| describe "layering porcelain and liquids" which are | ||
| applied to a pressed ceramic veneer which has been | ||
| previously pressed on a zirconium framework. Even | ||
| better, however, is the comparability of the corresponding | ||
| model variant (“MiYO Esthetic System Kit”) resulting from | ||
| this group, whose indication is identical to that of the new | ||
| product. | ||
| Product for veneering / | ||
| individualization of dental | ||
| frameworks | Yes | Yes |
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| Feature | Predicate Device | New Device |
|---|---|---|
| Framework material | Zirconium dioxide and | |
| lithium disilicate | Zirconium dioxide and | |
| lithium disilicate | ||
| Minimal amount of fires | 2 | 1 |
| For all sizes of dental | ||
| frameworks | Yes | Yes |
| Classification acc. to ISO | ||
| 6872 | Type 1, class 1b | Type 1, class 1b |
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| Feature | Predicate Device | New Device |
|---|---|---|
| Technological Characteristics | ||
| Material | Feldspar ceramics | Feldspar ceramics |
| Form | Pastes and liquids | Pastes and liquids |
| Shades | Different tooth and individualization shades | Different tooth and individualization shades |
| Tested according to ISO 6872 | Yes | Yes |
| Flexural strength [MPa] | $\ge$ 50 | $\ge$ 50 |
Substantial Equivalence Conclusion
Dental Direkt GmbH believes that the new product DD contrast is substantially equivalent to the predicate device when used as instructed by knowledgeable and trained dental personnel. There is no change of the intended use of the new device and no difference in fundamental scientific technology. The new device is made from the same materials as the predicate device. The new device was verified in accordance with the abovementioned FDA recognized standards.
Dental Direkt GmbH therefore believes that DD contrast is substantially equivalent to the legally marketed predicate device.