No
The summary describes a dental restorative material with color-matching properties, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is a restorative dental material used for filling cavities and sealing fissures, not for treating or rehabilitating a disease or injury.
No
LC ChromeFlow is a dental restorative material, meaning it is used to repair or restore a tooth's structure after damage or decay, rather than to diagnose a condition.
No
The device is described as a "flowable light cure resin based dental restorative material" and a "light cure flowable radiopaque composite," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that LC ChromeFlow is a dental restorative material used for filling cavities and other dental procedures. This is a direct treatment applied to the patient's tooth.
- Device Description: The description confirms it's a light cure flowable composite, a material used in dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health or condition. IVDs are typically used for diagnosis, monitoring, or screening.
Therefore, LC ChromeFlow falls under the category of a medical device used for treatment, not an IVD used for diagnosis or related purposes.
N/A
Intended Use / Indications for Use
LC ChromeFlow is a flowable light cure resin based dental restorative material which is indicated to be used for small restorations; extended fissure sealings; restorations of class III, IV and V and lining of cavities.
Product codes
EBF, EBC
Device Description
LC ChromeFlow is a light cure flowable radiopaque composite. LC ChromeFlow can be used for a lot of natural tooth shades due to its continuous color matching properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
The patient population is intended for all ages that need a restoration as prescribed by a dentist.
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)
Reference Device(s)
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.
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March 6, 2023
S&C Polymer Silicon- und Composite Spezialitaten GmbH Christian Boettcher Reg. Compliance Officer, Official Correspondent to FDA Robert-Bosch-Str. 2 Elmshorn, 25335 GERMANY
Re: K222445
Trade/Device Name: LC ChromeFlow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: February 1, 2023 Received: February 6, 2023
Dear Christian Boettcher:
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.
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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) 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 (QS) 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.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
LC ChromeFlow
Indications for Use (Describe)
- Small restorations
- Extended fissure sealings
- Restorations of class III, IV and V
- Lining of cavities
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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S&C Polymer GmbH | Robert-Bosch-Str. 2 | D-25335 Elmshorn
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center (DCC) - WO66-G609 10903 New Hampshire Avenue Silver Spring MD 20993-0002
United States of America
S & C Polymer
Silicon- und Composite Spezialitäten GmbH
Robert-Bosch-Str. 2 D - 25335 Elmshorn, Germany
Tel ++49 = (0) 4121 / 4 83-0 Fax ++49 - (0) 4121 / 4 83-1 81 regulatory@sc-polymer.com
file: 003_510(k) Summary_LC ChromeFlow.doc
Elmshorn, March 01st 2023
510(k) Summary - LC ChromeFlow - K222445
Dear Ladies & Gentleman,
attached you will find the 510(k) summary for the product LC ChromeFlow.
Sincerely yours,
Dr. Christian Boettcher Reg. Compliance Officer Official Correspondent to FDA
S & C Polymer
Silicon- und Composite
Spezialitäten Gmb
Robert Bosch-Straße 2
D-25335 Elmshorn/Germany
Tel. +49-(0) 41 21 / 483-0
Fax: +49-(0) 41 21 / 483-181
4
510(k) Summary
1. Submitter
| Name of company: | S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
|---|---|
| Address: | Robert-Bosch-Str. 2, 25335 Elmshorn, Germany |
| Phone: | 0049 4121 483 0 |
| Fax: | 0049 4121 483 184 |
| Contact person: | Dr. Christian Boettcher |
| Date prepared: | March 01st 2023 |
2. Device name
| Trade name: | LC ChromeFlow |
|---|---|
| Common name: | Tooth Shade Resin Material |
| Device classification name: | Material, Tooth Shade, Resin |
| Regulatory number: | 872.3690 |
| Product code: | EBF |
3. Predicate device
| Predicate device I: | LC GlossFill XR (S&C) |
|---|---|
| 510(k) Number: | K182778 (introduced into the US-Market 2019) |
| Predicate device II: | Tetric EvoFlow (Ivoclar Vivadent) |
| 510(K) Number: | K993783 (introduced into the US-Market 1999) |
| Referenced device: | LC Microhybrid (S&C Polymer) |
| 510(k) Number: | K984484 (introduced into the US-Market 1999) |
4. Device description
LC ChromeFlow is a light cure flowable radiopaque composite. LC ChromeFlow can be used for a lot of natural tooth shades due to its continuous color matching properties.
5. Intended use / Indications for use of the device
LC ChromeFlow is a flowable light cure resin based dental restorative material which is indicated to be used for small restorations; extended fissure sealings; restorations of class III, IV and V and lining of cavities. The indications for use of the subject device LC ChromeFlow is covered by the indications for use of the predicate devices LC Glossfill XR (S&C) and/or Tetric EvoFlow (Ivoclar Vivadent).
The patient population is intended for all ages that need a restoration as prescribed by a dentist.
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Device comparison with the predicate device 6.
The predicate devices has been found to be substantially equivalent under the 510(k) premarket notification as class II dental device under CFR 872.3690 product code EBF.
| | Subject device
LC ChromeFlow | Predicate device
LC Glossfill XR
(S&C) | Predicate device
Tetric EvoFlow
(Ivoclar Vivadent) |
|--------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended use | Flowable light cure
resin based dental
restorative material | Light cure resin
based dental
restorative material | Light-curing
flowable resin
based dental
restorative material |
| Mechanism of action | light cure | light cure | light cure |
| Form of delivery | -syringe
-application tips | -syringe
-application tips | -syringe
-preloaded tips
(named Cavifil) |
| Prescription use | yes | yes | yes |
| Appearance | paste | paste | paste |
| Indications for use | equal | equal | equal |
| Ingredients
(general description) | -methacylate-based
resins
-photo initiators
-fillers
-pigments | -methacylate-based
resins
-photo initiators
-fillers
-pigments | -methacylate-based
resins
-photo initiators
-fillers
-pigments |
| Physical properties | according to
ISO 4049 | according to
ISO 4049 | according to
ISO 4049 |
7. Conclusion
The comparison worked out above and the further elaboration of information within this 510(k) submission demonstrate that the subject device LC ChromeFlow is substantially equivalent to the predicate devices LC GlossFill XR (S&C) and Tetric EvoFlow (Ivoclar Vivadent) in terms of description, intended use, indications for use, chemical composition and physical properties. The information given above do not raise different questions of safety and effectiveness. The devices are as safe and effective as the predicate devices.