(155 days)
Not Found
No
The device description and intended use are for dental press pellets, a material used in fabrication. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are focused on material properties and biocompatibility.
No
The device is described as zirconia-reinforced lithium silicate press pellets for dental fabrications (e.g., crowns, veneers), which are materials used to create restorations, not to treat a disease or condition.
No
Explanation: The device description and intended use clearly state that VITA AMBRIA are press pellets used for fabricating dental restorations (e.g., crowns, veneers, inlays). This is a material used for treatment/restoration, not for diagnosing a condition or disease.
No
The device description clearly states that VITA AMBRIA are "zirconia-reinforced lithium silicate press pellets," which are physical materials used in dental restorations. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe the fabrication of dental restorations (veneers, inlays, crowns, bridges, etc.) for use in the mouth of a patient. This is a direct application to the human body for therapeutic or restorative purposes.
- Device Description: The device is described as press pellets for fabricating these dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body as a restorative material.
N/A
Intended Use / Indications for Use
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique.
Indications
•Occlusal veneers (table tops), veneers
•Inlays, onlays, partial crowns
•Crowns in the anterior and posterior areas
•3-unit anterior bridges up to the second premolar
•Single tooth restorations as implant suprastructures for anterior and posterior teeth
•3-unit bridges as implant suprastructures up to the second premolar
•Single tooth mesostructures in the anterior and posterior areas
•Abutment crowns in the anterior and posterior areas
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.
VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets.
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)
Non-Clinical Performance Testing: VITA Ambria® meets the applicable requirements of the following FDA recognized standards:
- DIN EN ISO 6872 2015 - Dentistry - Ceramic Materials
- ISO 10993-1:2009 - Biological evaluation of medical devices
- ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
Bench test results allowed us to conclude that VITA Ambria® is substantially equivalent to the predicate device for its intended use.
Biocompatibility: A biocompatibility assessment was performed on VITA Ambria® in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA Ambria® is biocompatible and concludes that the device is safe for its intended use.
Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Ambria®.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.
May 14, 2020
VITA Zahnfabrik GmbH H Rauter & Co % Lindsay Tilton Regulatory Affairs Consultant VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887
Re: K193436
Trade/Device Name: VITA Ambria® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 10, 2020 Received: February 14, 2020
Dear Lindsay Tilton:
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, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K193436
Device Name VITA Ambria®
Indications for Use (Describe)
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique.
Indications
•Occlusal veneers (table tops), veneers
- •Inlays, onlays, partial crowns
- ·Crowns in the anterior and posterior areas
- ·3-unit anterior bridges up to the second premolar
- ·Single tooth restorations as implant suprastructures for anterior and posterior teeth
- ·3-unit bridges as implant suprastructures up to the second premolar
- · Single tooth mesostructures in the anterior and posterior areas
- · Abutment crowns in the anterior and posterior areas
| 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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3
510(k) Summary
| Submitter | VITA Zahnfabrik H.Rauter GmbH Co.
Spitelgasse 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality Systems
Phone (+49) 7761 562-361
Fax (+49) 7761 562-384
B.Walker@vita-zahnfabrik.com |
| Official Correspondent | Lindsay Tilton
Regulatory Affairs & Compliance Consultant
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (925)699-9091
Fax (714) 221-6759
E-mail: Itilton@vitanorthamerica.com |
| Date Prepared | May 11, 2020 |
- " Trade/Device Name Vita Ambria®
- " Classification Name Porcelain powder for clinical use
- י Regulation Number 21 CFR 872.6660
- י Product Code EIH
4
Predicate Devices
VITA PM7; PM9 - K050362 – Primary Predicate Device
Device Description
VITA Ambria® VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.
VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets. Below are all the available shades:
| LAM030S0365 | VITA AMBRIA®, A1-T, S, 5 pcs. |
|---|---|
| LAM030S0375 | VITA AMBRIA®, A2-T, S, 5 pcs. |
| LAM030S0385 | VITA AMBRIA®, A3-T, S, 5 pcs. |
| LAM030S0415 | VITA AMBRIA®, B1-T, S, 5 pcs. |
| LAM030S0425 | VITA AMBRIA®, B2-T, S, 5 pcs. |
| LAM030S0465 | VITA AMBRIA®, C2-T, S, 5 pcs. |
| LAM030S0495 | VITA AMBRIA®, D2-T, S, 5 pcs. |
| LAM040S0365 | VITA AMBRIA®, A1-HT, S, 5 pcs. |
| LAM040S0375 | VITA AMBRIA®, A2-HT, S, 5 pcs. |
| LAM040S0385 | VITA AMBRIA®, A3-HT, S, 5 pcs. |
| LAM040S0415 | VITA AMBRIA®, B1-HT, S, 5 pcs. |
| LAM040S0425 | VITA AMBRIA®, B2-HT, S, 5 pcs. |
| LAM040S0465 | VITA AMBRIA®, C2-HT, S, 5 pcs. |
| LAM040S0495 | VITA AMBRIA®, D2-HT, S, 5 pcs. |
| LAM030L0363 | VITA AMBRIA®, A1-T, L, 3 pcs. |
| LAM030L0373 | VITA AMBRIA®, A2-T, L, 3 pcs. |
| LAM030L0383 | VITA AMBRIA®, A3-T, L, 3 pcs. |
| LAM030L0413 | VITA AMBRIA®, B1-T, L, 3 pcs. |
| LAM030L0423 | VITA AMBRIA®, B2-T, L, 3 pcs. |
| LAM030L0463 | VITA AMBRIA®, C2-T, L, 3 pcs. |
| LAM030L0493 | VITA AMBRIA®, D2-T, L, 3 pcs. |
| LAM040L0363 | VITA AMBRIA®, A1-HT, L, 3 pcs. |
| LAM040L0373 | VITA AMBRIA®, A2-HT, L, 3 pcs. |
| LAM040L0383 | VITA AMBRIA®, A3-HT, L, 3 pcs. |
| LAM040L0413 | VITA AMBRIA®, B1-HT, L, 3 pcs. |
| LAM040L0423 | VITA AMBRIA®, B2-HT, L, 3 pcs. |
| LAM040L0463 | VITA AMBRIA®, C2-HT, L, 3 pcs. |
| LAM040L0493 | VITA AMBRIA®, D2-HT, L, 3 pcs. |
| LAM030S0025 | VITA AMBRIA®, 0M1-T, S, 5 pcs. |
| LAM030S0045 | VITA AMBRIA®, 0M3-T, S, 5 pcs. |
| LAM040S0025 | VITA AMBRIA®, 0M1-HT, S, 5 pcs. |
| LAM040S0045 | VITA AMBRIA®, 0M3-HT, S, 5 pcs. |
| LAM030L0023 | VITA AMBRIA®, OM1-T, L, 3 pcs. |
| LAM030L0043 | VITA AMBRIA®, OM3-T, L, 3 pcs. |
| LAM040L0023 | VITA AMBRIA®, OM1-HT, L, 3 pcs. |
| LAM040L0043 | VITA AMBRIA®, OM3-HT, L, 3 pcs. |
| LAMSKC | VITA AMBRIA® STARTER KIT VITA classical A1-D4° |
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Statement of Intended Use
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.
Indications
- •Occlusal veneers (table tops), veneers
- •Inlays, onlays, partial crowns
- •Crowns in the anterior and posterior areas
- · 3-unit anterior bridges up to the second premolar
- Single tooth restorations as implant suprastructures for anterior and posterior teeth
- •3-unit bridges as implant suprastructures up to the second premolar
- •Single tooth mesostructures in the anterior and posterior areas
- · Abutment crowns in the anterior and posterior areas
Technological Characteristics
VITA Ambria contains the above components in an insoluble glass matrix similar to VITA PM9 that is used to fabricate restorations in the press technique.
Non-Clinical Performance Testing
VITA Ambria® meets the applicable requirements of the following FDA recognized standards:
- DIN EN ISO 6872 2015 - Dentistry - Ceramic Materials
- 트 ISO 10993-1:2009 - Biological evaluation of medical devices
- ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
Bench test results allowed us to conclude that VITA Ambria® is substantially equivalent to the predicate device for its intended use.
Biocompatibility
A biocompatibility assessment was performed on VITA Ambria® in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
6
within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA Ambria® is biocompatible and concludes that the device is safe for its intended use.
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Ambria®.
| | Subject Device | Primary Predicate
Device |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | VITA Ambria® AC | VITA PM |
| Device Classification | Porcelain Powder
For Clinical Use | Porcelain Powder
For Clinical Use |
| Product Code | EIH | EIH |
| Regulation Number | 21 CFR 872.6660 | 21 CFR 872.6660 |
| Indication for use | • Occlusal veneers
(table tops), veneers
• Inlays, onlays, partial
crowns
• Crowns in the
anterior and posterior
areas
• 3-unit anterior
bridges up to the
second premolar
• Single tooth
restorations as
implant
suprastructures for
anterior and posterior
teeth
• Single tooth
mesostructures in the
anterior and posterior
areas
• Abutment crowns in
the anterior and
posterior areas | o Single and multi-
surface inlays
o Onlays
o Veneers
o Partial crowns
o Anterior crowns o
Premolar crowns
Also for oxide-ceramic
crown and bridge
substructures to be
veneered with
conventional
porcelain. |
Table Comparison to Predicate Devices
7
| Components | Lithium silicate | Lithium silicate |
|---|---|---|
| Technology comparison | Pellets in various shades | Pellets in various shades |
| Sterile | Non Sterile | Non Sterile |
| Principle of operation | for the fabrication of restorations in the press technique | for the fabrication of restorations in the press technique |
| Performance Testing | Complies to ISO 6872 | Complies to ISO 6872 |
| Biocompatibility Testing | Complies to ISO 10993-1 | Complies to ISO 10993-1 |
The indications for use are more detailed for the Ambria device, but cover the same indications for the predicate. The indication of the predicate is comparable to that of the new device, even if it is written in a very general way. The subject device lists out all the different substrates it can be used with, while the predicate leaves the terms more general. Both cover the same indications and no additional indications are added to the subject device, therefore this does not affect the substantial equivalence.
Conclusion
Information provided in this application demonstrates that VITA Ambria® is substantially equivalent to the legally marketed predicate device.