(46 days)
Not Found
No
The device description and intended use focus on the material properties and application of a dental composite, with no mention of AI or ML capabilities.
No.
The device is a flowable composite used for dental restorations, which is a material used for treatment, but not a therapeutic device in itself designed to produce a therapeutic effect on the body system.
No
The device is a restorative material used for dental fillings and sealants, not for diagnosing medical conditions.
No
The device description clearly states it is a light-cured self-etching, self-adhesive composite, which is a physical material, 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 light-cured dental restorations, including filling cavities and sealing pits and fissures. This is a direct treatment applied to the patient's teeth.
- Device Description: The device is a composite material used to physically restore tooth structure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (within the body) as a restorative material.
N/A
Intended Use / Indications for Use
Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:
- Self-etch base liner
- Restorations of carious lesions
- Class 1, III, and V cavity preparations
- Pit and fissure sealant.
Product codes
EBF
Device Description
The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared.
Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentition / Oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinician
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)
A review for safety and effectiveness was performed and found not to have been affected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
§ 872.3690 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/1 description: The image shows the logo for Pentron Clinical Technologies, LLC. The logo features the company name in a simple, sans-serif font, with "Pentron" appearing on the top line and "Clinical" on the second line. Below the company name, the text "Technologies, LLC" is displayed in a smaller font size. The tagline "Advancing dentistry one innovation at a time!" is located at the bottom of the image.
OCT 2 6 2007
510(K) SUMMARY 6.0
Pentron Clinical Technologies, LLC. 68 North Plains Industrial Road Wallingford, CT 06492 203-265-7397 Tel: 203-284-4986 Fax: Contact: Greg Moreau ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Artiste SE Flowable Composite Trade Name: Bonding Agent Common Name: Classification Name: Material, Tooth Shade, Resin, 21CFR 872.3690, EBF ==============================================================================================================================================================================
Artiste SE Flowable Composite product, as a suitable dental restorative material, performs similar intended functions as its predicate device, Embrace Wet-Bond Restorative Materials (reference K031877). Both devices are intended to provide the dental clinician a safe and effective method to repair dentition using a variety of technique applications. Applications include:
- 트 Self-etch base liner
- 트 Restorations of carious lesions
- Class 1, III, and V cavity preparations 트
- Pit and fissure sealant. I
The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared.
Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.
A review for safety and effectiveness was performed and found not to have been affected.
510(k) Submission for Artiste SE Flowable Composite
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 2007
Mr. Greg Moreau Quality Systems, Manager Pentron Clinical Technologies, LLC 68- 70 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K072545
Trade/Device Name: Artiste SE Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 6, 2007 Received: September 10, 2007
Dear Mr. Moreau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2- Mr. Moreau
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Neil R. Ogden
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
5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): 《 0 7 2 5 4 5 -
DEVICE NAME: Artiste SE Flowable Composite
INDICATION FOR USE:
Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:
- 트 Self-etch base liner
- 트 Restorations of carious lesions
- Class 1, III, and V cavity preparations
- I Pit and fissure sealant.
Syper Rives
( Tulsion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K072545
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ู้ Prescription Use (Per 21 CFR 801.109)
OR
Over –The-Counter-Use (Optional Format 1-2-96)
510(k) Submission for Artiste SE Flowable Composite