(72 days)
K 040144
K 994056, K 926458, K 040769, K 030914, K 912425
No
The 510(k) summary describes a dental filling material and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a restorative material for fillings, not a therapeutic device designed to treat a disease or condition. Its function is to fill cavities, which is a structural repair.
No
The device, x-tra fil, is described as a "hybrid resin composite restorative material for use in filling posterior dental cavities." Its intended use is for "light curing class I and class II posterior fillings and core build-up." This indicates it is a therapeutic material used in treatment, not a device designed to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a "hybrid resin composite restorative material," which is a physical substance, not software.
Based on the provided information, the device "x-tra fil" is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "light curing class I and class II posterior fillings and core build-up." This describes a material used directly in the body for restorative purposes in dentistry.
- Device Description: The description confirms it's a "hybrid resin composite restorative material for use in filling posterior dental cavities." This further reinforces its use as a dental filling material.
- Lack of IVD Characteristics: IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. The description of x-tra fil does not involve any such testing or analysis of biological samples.
Therefore, x-tra fil is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
x-tra fil is indicated for posterior Class I and Class II cavities and core build-up.
x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.
Product codes
EBF
Device Description
x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth cavities / 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Quixx Posterior Restorative K 040144
Reference Device(s)
K 994056, K 926458, K 040769, K 030914, K 912425
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "VOCO" in a stylized font. Above the word is the text "K053391, jp/1951". The letters of the word "VOCO" are represented by geometric shapes. The "V" is an upside-down triangle with a rectangle cut out of the top, the "O" is a circle with a smaller circle cut out of the center, the "C" is a circle with a wedge cut out of it, and the last "O" is a circle with a smaller circle cut out of the center.
1
FEB 1 5 2006
| | VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany | | | | Anton-Flettner-Straße 1 - 3
27472 Cuxhaven · Germany | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------|--|---------------------------------------------------------|----------------|
| | | | | | | +49 4721 719-0 |
| | | | | | 04721 719-109
+49 4721 719-140 | |
| | | | | | www.voco.de
info@voco.de | |
| | | | | | | |
| Ihr Zeichen
yr ref. | Ihre Nachricht vom
dtd. | Unser Zeichen
our ref. | Datum
date | | | |
| | 510(k) SUMMARY | | | | | |
| Contact: | Dr. Süs | | | | | |
| Date prepared: | November 29, 2005 | | | | | |
| Trade or
proprietary name: | x-tra fil | | | | | |
| Classification name: | Tooth shade resin material (872.3690) | | | | | |
| Predicate device: | Quixx Posterior Restorative K 040144 | | | | | |
| Device description: | x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured. | | | | | |
| Intended use: | x-tra fil is indicated for posterior Class I and Class II cavities and core build-up. | | | | | |
| Technological
characteristics: | All of the components of x-tra fil are found in the legally marketed devices K 040144, K 994056, K 926458, K 040769, K 030914, K 912425. | | | | | |
| | The prior use of all of the components of x-tra fil in legally marketed devices support our | | | | | |
The prior use of all of the components of x-tra fil in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.
We believe that the prior use of the components of x-tra fil in legally marketed devices and the performance data and results provided support the safety and effectiveness of x-tra fil for the intended use.
VOCO GmbH, November 29, 2005
Dr. Michael Sus Mgr. for regulatory affairs
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Dr. Michael Sus Manager Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany D-27472
Re: K053391
KUJ3391
Trade/Device Name: x-tra fil is Intended for light curing Class I and class II Posterior Fillings and Core Build-up Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 29, 2005 Received: December 7, 2005
Dear Dr. Sus:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection 910(4) personally equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate collineree pror to may 20, 77 % a cordance with the provisions of Amendinens, of to devices that have ober (Act) that do not require approval of a premarket the rederal Pood, Drug, and Cosment Proc (Prov market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Feat - the girling of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 a0010) in a controls. Existing major regulations affecting (FMA), it may oc subject to backs and readers, Title 21, Parts 800 to 898. In your device can be found in the Sous of Concerning your device in the Ecderal Register.
2
Page 2 - Dr. Sus
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualled of a basetan requires with other requires mean that FDA has made a decemination until Js administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other frequires in of the Act of any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including progrises You must comply with an the Act 3 requirement 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 CFR rate 77 //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 // 1ha requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 (0(k) This letter will antw you to begin matically your device of your device to a premarket nothreation. The PDA miding of basically of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CH'R Part 801), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation
Please contact the Office of Compliance at (240) 276-0115. Also, please note presse contact une Office or Comphanos are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binar-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K053391
Device Name: x-tra fil___
Indications for Use:
x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Cuomo
Division of Anesthesiology, General Hospital,
fection Control, Dental Devices
21000 Number 2/15/04