(84 days)
N/A
No
The device description and other sections do not mention any AI or ML technology. The device is a set of stains for dental restorations.
No.
The device is used for shade customization and characterization of dental restorations for esthetic purposes and does not claim to treat or prevent any disease or condition.
No
Explanation: The device is indicated for shade customization and characterization of dental restorations, which are aesthetic purposes, not diagnostic. The document explicitly states, "The intended use of the device is for esthetic purposes only. For this reason, performance Data was not pursued."
No
The device description clearly states it is a physical product (color intensive resins in powder form) used for staining dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "shade customization and characterization of the surface of dental restorations." This is an aesthetic and restorative purpose, not for diagnosing a disease or condition.
- Device Description: The description details a material used to alter the appearance of dental restorations outside the mouth. It's a physical material applied to a pre-existing restoration.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status.
- Performance Studies: The document explicitly states that "performance Data was not pursued" because the intended use is for "esthetic purposes only." This further reinforces that it's not a diagnostic device, which would require performance data related to accuracy in detecting or measuring something.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
Product codes
EBD
Device Description
The Vita Enamic® Stains are color intensive resins used for shade characterization of the Vita Enamic® restorations. The shades are supplied in powder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic® restoration to adjust the shade or create characteristics found in natural teeth, such as cracks. The surface of the painted restoration is then sealed with a clear light-curing glaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing polymerization that is prepared outside the mouth.
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)
The intended use of the device is for esthetic purposes only. For this reason, performance Data was not pursued.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
510(k)982259 Chroma Zone Color Stain, 510(k)024046 Biscover XT/ Tesera Glazing Resin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence appears to be "K123761". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters slightly distorted.
——
ﻧﺮ
Image /page/0/Picture/1 description: The image shows a logo for Innovation MediTech, which is a Dreve Company. The logo is circular and contains the words "innovation" and "MediTech" stacked on top of each other. Below the circle, the text "A Dreve Company" is written in a smaller font.
510(k) Summary
MAR 0 1 2013
| • Submitter | Innovation MediTech GmbH
Max-Planck-Straße 31
Unna, Nordrhein-Westfalen, 59423
Germany
Establishment Reg No. 3004003391 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| • Contact | Dr. Reiner Altmann
Head of Quality Management and Safety Representative for
medical devices
Ph. (+49) 2303 - 88070
e-mail: reiner.altmann@dreve.de | |
| • Official Correspondent | Elizabeth Wolfsen
Regulatory Affairs Specialist
Vident, a Vita Company
3150 E. Birch Street
Brea, CA 92821
Establishment Reg. No. 2082832
Ph (714) 961-6268
Fx (714) 961-6200
e-mail: ewolfstein@vident.com | |
| • Date Prepared | December 1, 2012 | |
| • Trade/Device Name: Enamic® Stains
• Common Name: Stain and Glaze
• Classification Name: Coating, Filling Material, Resin
• Class II per 21 CFR 872.3310,
• Product Code: EBD | | |
| | Predicate Devices: 510(k)982259 Chroma Zone Color Stain
510(k)024046 Biscover XT/ Tesõera Glazing Resin | |
| Innovation MediTech GmbH
Max-Planck-Str. 31
59423 Unna / Germany
Tel. +49 2303 8807-0
Fax +49 2303 8807-39
info@meditech-dreve.com
www.meditech-dreve.com | Lieferadresse: Einsteinstr. 35
Geschäftsführer: Dr. Volker Dreve
Ust-IdNr.: DE811240540
Amtsgericht Hamm HRB 4211 | Sparkasse Unna
Kto.-Nr. 456 52
BLZ 443 500 60
IBAN: DE 33 44350060
00000045652
BIC: WELADED1UNA |
1
Image /page/1/Picture/0 description: The image shows a logo for Innovation Meditech, which is a Breve Company. The logo is a black circle with the words "Innovation Meditech" written in white letters inside. The words are stacked on top of each other, with "Innovation" on top and "Meditech" on the bottom. The words "A Breve Company" are written in black letters below the circle.
Device Description
The Vita Enamic 6 Stains are color Intensive resins used for shade characterization of the The Vita Enamic restorations made from Vita Enamic The shades are supplied in sonder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic restoration to adjust the shade or create characteristics found in natural teeth, such as cracks, restoration to of the painted restoration is then sealed with a dear light-curing allaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing create a sinopon one phymenzation that is prepared outside the mouth.
Statement of Intended Use:
Vita Enamic ® Statis are Indication shade customization and characterization of the surface of dentál restorations made of hybrid ceramic-resin and resin materials.
Substantial Equivalence
Information provided in this applingtion shows that the product is substantially equivalent to the predicate devices in Intended use, materials, application, and polymerization methods.
Technological Characteristics
Design
The Vita Enamic Stains are similar in design the the predicates listed allove. Like the predicates, the Enamic Stains are intended to be applied in-vitro for the purpose of manipulating the shade or adding characteristills to a dental restoration to ensure proper matching of the patient's natural teeth.
Unlike the gredicates, Vija Enamis Stains are not offéred in paste form, but in separated powder and figuld form. This allows the user full control of the stain intensity by the measure of liquid used with the powder. The Enamic Stains also Include a glazing Equild to seal In the stains which protect the stath from wearing off and create a smooth, plossy sufface to the finished device.
Material
Like the prodicate materials, the Vita Enamic is based on multifunction An ass Like the program IIIiii according to FDA Recognized Consensus Standard ISO 10998 B In this application. We conduce, as a result of this assessment/testing, that the device for its interided use. స్త
Summary of Non-Cilnical Performance Data
The intended use of the device is tor esthetic purposes only. For this reason, performance Data was not pursued.
Image /page/1/Picture/24 description: The image shows a circular logo with a thick black ring around a smaller white circle. Inside the white circle, there appears to be some text, but it is not legible due to the image quality. The logo has a small white portion at the top, creating a crescent shape within the black ring.
generation. Modification expected
గ్రామం...
11255
Sparkasse Unna
Kto. Nr. 404 93
(BLZ 443 500 60)
Bank-Kto. 1405060
Commerzbank AG Dortmund
Tel. 0231 222 40 800
BLZ 440 800 50
Kto.-Nr./Depot 44050050
DESCRIPTION OF PROPOSED WORK
.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Innovation MediTech, GmbH C/O Ms. Elizabeth Wolfsen Regulatory Affairs Specialist Vident 3150 East Birch Street BREA CA 92821
Re: K123761
Trade/Device Name: Vita Enamic Stains Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: December 1, 2012 Received: December 12, 2012
Dear Ms. Wolfsen:
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. 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.
3
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Director
Image /page/3/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a stylized font. The letters "KO" are connected and have a design around them. To the right of the name is the word "for" in a smaller, simpler font.
Anthony D. Watson, B.S., M.S., M.B.A. Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a logo for Innovation MediTech, which is inside of a circle. Below the circle, the text "A Dre .r Certisa," is present. The logo is black and white.
Indications for Use
510(k) Number (if known):
Device Name: Vita Enamic* Stains Indications for Use:
Vita Enamic" Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
Prescription Use × (21 CFR Pan 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
Susan Runner, DDS, MPA 2013.02.27
12:10:15 -05'00'
(Division Sign Off)
Drision of Dental Infection Control and General Hospital Devices
510:k; Numbe: K123761
Prescription Use (Par. 21 CFR 801.109 OR
Over-The-Counter Use
Page 1 of
Image /page/4/Picture/18 description: The image shows a circular logo with the text "TUV NORD" at the top. Below that is some smaller text that is difficult to read. The outer ring of the circle contains the text "ISO 9001 ISO 13485".
1428-Piar (k.53) 31 5942 | Unita / Germat , p 161 Fac. +49 3307 82909 www.innovation-meditech con-
newsGinneation modilects de
Innovation MediTesh GmbH
Deferactive. [ Holenstrati 35 Geschäftslutier, Di Volker Dreve 5itz 59421 Unna Reg -Gericht: H.snin HRB 4213
Sparkasse Unna ktn, tir, 404 63 (812 443 500 60). IBAN: DE 09 44350060 000040453 BIC: WELADLD IUNN
Commerchani AG Dorimund 4: 0} 777 40 Ext (612 440 Bod 50). IBAN. DE 26 44080050 0322240500 BIC: DRESDELLAND