(154 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a dental composite, with no mention of AI or ML.
No
Explanation: The device is a dental restorative material used for repairing teeth, not for treating diseases or conditions.
No
Explanation: The device is a restorative dental composite used for repairing and restoring teeth, not for diagnosing medical conditions.
No
The device description clearly states it is a "light cure resin-based flowable restorative dental composite" packaged in "capsules and syringes" and contains "radiopaque inorganic fillers and advanced nano-silicas," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health.
- This device is a dental restorative material. It is used to repair teeth directly in the mouth. It is not used to analyze samples taken from the body.
The description clearly indicates its use in dental procedures on the tooth itself, not for testing biological samples.
N/A
Intended Use / Indications for Use
OptiFlow II Flowable Composite, LC is intended for use as:
- Repair of minimally invasive cavity (including non-stress bearing areas)
- Pit and fissure sealant
- Class III-V restorations
- Repair of porcelain restorations
- Repair of ceramic/composite veneers
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.
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)
This 510(k) submission includes data from bench testing to evaluate the performance of OptiFlow II Flowable Composite compared to predicate device Filtek™ Supreme Ultra Flowable Restorative. Properties evaluated include Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength and Rockwell Hardness.
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.
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
Section IV
510(k) Summary
Submitter: Pac-Dent International, Inc. 21038 Commerce Point Dr. Walnut, CA91789
AUG 1 3 2013
Contact Person:
Wenying Zhu Materials Scientist 909-839-0888 ext. 111
Date Summary Prepared: January 2013
Device Name
Trade Name: OptiFlow II Flowable Composite, LC Common Name: Flowable light cure provisional add-on material Classification Name: Tooth shade Resin Material, per 21 CFR 872.3690
Predicate Device Filtek™ Supreme Ultra Flowable Restorative (K100235)
Description of Device
OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.
Indications for Use
Repair of minimally invasive cavity (including non-stress bearing areas) Pit and fissure sealant
1
Class III-V restorations Repair of porcelain restorations Repair of ceramic/composite veneers
Summary of Biocompatibility Tests
OptiFlow II Flowable Composite, LC is substantially equivalent to the predicate device Filtek"M Supreme Ultra Flowable Restorative in terms of materials and technological properties. It is also substantially equivalent to CuRAY Match Paint-On Composite Restor (K833810) which is produced by the same manufacturer in terms of manufacturing process. No biocompatibility test is required to establish substantial equivalence for OptiFlow II Flowable Composite, LC.
Summary of Physical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of OptiFlow II Flowable Composite compared to predicate device Filtek™ Supreme Ultra Flowable Restorative. Properties evaluated include Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength and Rockwell Hardness.
Substantial Equivalence
OptiFlow II Flowable Composite, LC is substantially equivalent to the predicate device Filtek™ Supreme Ultra Flowable Restorative in terms of indications for use, composition of materials and physical properties. Physical properties evaluated include Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength and Rockwell Hardness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of a caduceus, a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2013
Pac-Dent International, Incorporated C/O Dr. Wenying Zhu Materials Scientist 21038 Commerce Point Drive Walnut, CA 91789
Re: K130672
Trade/Device Name: OptiFlow II Flowable Composite, LC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 29, 2013 Received: June 4, 2013
Dear Dr. Zhu:
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
Page 2 - Dr. Zhu
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 (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director 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 the logo for PacDent International, Inc. The logo features the company name in a stylized font, with the word "PacDent" in bold letters and the tagline "passion for excellence..." underneath. The logo is set against a dark background, with a white swoosh design element above the company name. The overall design is modern and professional.
Image /page/4/Picture/1 description: The image is a black and white photograph that appears to be a close-up of a textured surface. The surface has a grainy and uneven appearance, with a mix of light and dark areas. The texture is complex and irregular, with no clear pattern or structure. The image is high contrast, with sharp transitions between light and dark areas.
.- Dent International, Inc. 21038 Commerce Pointe Dr. Walnut • California • 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section III
Indications for Use Statement
510(k) Number (if known): K130672
OptiFlow II Flowable Composite, LC Device Name: _
Indications for Use:
OptiFlow II Flowable Composite, LC is intended for use as:
- Repair of minimally invasive cavity (including non-stress bearing areas) ●
OR
/
- Pit and fissure sealant
- � Class III-V restorations
- t Repair of porcelain restorations
- . Repair of ceramic/composite veneers
Prescription Use
Over-The-Counter Use _
Sheena A. Greens S. 2013.08.07 10:29:43=04'00"
for M. Susan Runner, DDs, MA
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number;_
Image /page/4/Picture/21 description: The image shows several certification logos. From left to right, there is the NQA logo with ISO 13485:2003 and ISO 9001:2008 written below it, the UKAS logo with the number 015, the TUV logo, the FDA logo, and the CE logo with the number 0197. These logos indicate that the product or organization has met certain standards and requirements.