DiaTemp Flow

K192022 · DiaDent Group International · EBG · Feb 13, 2020 · Dental

Device Facts

• Record ID: K192022
• Device Name: DiaTemp Flow
• Applicant: DiaDent Group International
• Product Code: EBG · Dental
• Decision Date: Feb 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Temporary inlay and onlay treatments of the cavity. 2. Sealing of openings for implant screws. 3. Relining material for temporary crowns and bridges. 4. Covering of the gingival margin. 5. Fixing of resin matrix during filling placement.

Device Story

DiaTemp Flow is a light-curing temporary filling material used in dental clinics by professionals. Supplied in syringes with disposable tips and protective caps; available in yellow or blue. Applied to cavities, implant screw openings, or temporary crowns/bridges; sets upon exposure to curing light. Provides temporary restoration until permanent treatment. Benefits include ease of use for temporary sealing and protection of dental structures during interim periods. Healthcare providers use the material to maintain cavity integrity and patient comfort between appointments.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including ISO 4049 (polymer-based restorative materials) and ISO 10993 series (biocompatibility, cytotoxicity, sensitization, systemic toxicity, and implantation).

Technological Characteristics

Light-curing resin-based temporary filling material. Composition includes BHT, Camphorquinone, Ethyl 4-(N,N-dimethylamino)benzoate, and amorphous fumed silica. Form factor: syringe with disposable tip. Conforms to ISO 4049, ISO 7405, and ISO 10993 standards. Prolonged exposure (24 hours to 30 days).

Indications for Use

Indicated for temporary dental restorations, including inlay/onlay treatments, sealing implant screw openings, relining temporary crowns/bridges, covering gingival margins, and fixing resin matrices during filling placement. Prescription use only.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Clip Flow (K153493)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 13, 2020

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, 28161 KOREA

Re: K192022

Trade/Device Name: DiaTemp Flow Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: October 1, 2020 Received: October 1, 2020

Dear Kab Lee:

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.

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192022

Device Name DiaTemp Flow

Indications for Use (Describe)

- 1. Temporary inlay and onlay treatments of the cavity.
- 2. Sealing of openings for implant screws.
- 3. Relining material for temporary crowns and bridges.
- 4. Covering of the gingival margin.
- 5. Fixing of resin matrix during filling placement.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5.0 510(k) Summary

# 5.1 Application Information

| Date Prepared | February 11, 2020 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-<br>si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person | Kab Sun Lee<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 5.2 Device Information

| Device Type | Crown And Bridge, Temporary, Resin |
|------------------------|------------------------------------|
| Regulation Description | Temporary crown and bridge resin. |
| Review Panel | Dental |
| Regulation Number | 21 CFR 872.3770 |
| Product Code | EBG |
| Device Class | II |
| Device Name | DiaTemp Flow |

# 5.3 Predicate Devices

The legally marketed device to which substantial equivalence is being claimed is:

| 510(k) Number | K153493 |
|-------------------|-----------------|
| Applicant | VOCO GmbH |
| Device Name | Clip Flow |
| Regulation Number | 21 CFR 872.3690 |
| Product Code | EBF |
| Device Class | II |

## 5.4 Device Description

DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap.

| Model Name | Color | Weight |
|------------------------------------|--------|--------|
| DiaTemp Flow Yellow 1.8g | Yellow | 1.8g |
| DiaTemp Flow Blue 1.8g | Blue | 1.8g |
| DiaTemp Flow Yellow Intro kit 0.5g | Yellow | 0.5g |
| DiaTemp Flow Blue Intro kit 0.5g | Blue | 0.5g |

# 5.5 Indication for Use

- 1. Temporary inlay and onlay treatments of the cavity.
- 2. Sealing of openings for implant screws.
- 3. Relining material for temporary crowns and bridges.
- 4. Covering of the gingival margin.
- 5. Fixing of resin matrix during filling placement.

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# Product Name: DiaTemp Flow

# 5.6 Clinical Performance Data

No clinical data was collected or provided to support substantial equivalence between the subject and predicate device.

# 5.7 Non-Clinical Performance Data

This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

- ISO 4049:2009, Dentistry Polymer-based restorative materials
- ISO 7405:2009, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- ISO 10993-1:2009, Evaluation and testing within a risk management process
- ISO 10993-2:2006, Animal welfare requirements
- ... ISO 10993-3:2014, Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009, Tests for in vitro cytotoxicity
- ISO 10993-6:2016, Tests for local effects after implantation
- ISO 10993-10:2010, Tests for irritation and skin sensitization
- ISO 10993-11:2017, Tests for systemic toxicity ●
- ISO 10993-12:2012, Sample preparation and reference materials

# 5.8 Technological Characteristics

The technological comparison of the subject device to the predicate device is as follows.

| | Subject Device | Primary Predicate Device | Discuss |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | | K153493 | |
| Product code | EBG | EBF | |
| Applicant | DiaDent<br>Group<br>International | VOCO GmBH | |
| Device Name | DiaTemp Flow | Clip Flow | |
| Indications for<br>Use | 1. Temporary inlay and<br>onlay treatments of the<br>cavity.<br>2. Sealing of openings for<br>implant screws.<br>3. Relining material for<br>temporary crowns and<br>bridges.<br>4. Covering of the gingival<br>margin.<br>5. Fixing of resin matrix<br>during filling placement. | 1. Temporary inlay and<br>onlay treatments of the<br>cavity.<br>2. Sealing of openings for<br>implant screws.<br>3. Relining material for<br>temporary crowns and<br>bridges.<br>4. Block-out material for<br>retentive areas in the<br>dental arch, e.g. before<br>taking impressions.<br>5. Covering of the gingival<br>margin.<br>6. Fixing of resin matrix<br>during filling placement. | Equivalent |
| Description | DiaTemp Flow is a<br>temporary filling<br>material that sets with<br>curing light.<br>In case the cavity is not<br>permanently<br>restored, DiaTemp Flow<br>can be used<br>as a temporary restoration<br>until the<br>next appointment. | Clip Flow is a flowable,<br>light-curing material for<br>temporary fillings,<br>sealings and treatments.<br>Thanks to its elastic<br>consistency, the material<br>is easily removable, also<br>in case of undercuts.<br>Therefore, post-treatment<br>of the cavity is not<br>necessary. | Equivalent |

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# DiaDent Group International

# Product Name: DiaTemp Flow

| Package | ·Syringe | •Syringe | Equivalent |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Contents | •Disposable Tip | •Disposable Tip | |
| | ·Protective Cap | | |
| Composition | ВНТ<br>Camphorquinone<br>Ethyl 4-<br>(N,Ndimethylamino)benzo | ВНТ<br>2-hydroxyethyl metha-<br>crylate<br>Urethane Methacrylate | The main ingredients are<br>similar. Also,<br>biocompatibility and<br>performance tests |
| | ate | Pyrogenic silicic acids | demonstrate that |
| | silica amorphous,fumed | catalyst | DiaTemp Flow and the<br>predicate device are<br>substantially equivalent. |
| Performance | | | |
| Standard | ISO4049 | ISO4049 | Equivalent |
| Conformance | | | |
| Physical<br>and<br>Mechanical<br>Properties | -Sensitivity to ambient<br>light<br>-Depth of cure<br>-Shade & Colour stability<br>-Water sorption &<br>solubility | -Sensitivity to ambient<br>light<br>-Depth of cure | Equivalent |
| Period of Use | Prolonged exposure(B)<br>(exceed 24 hours but not<br>30 days) | Prolonged exposure(B)<br>(exceed 24 hours but not<br>30 days) | Equivalent |
| Bio-<br>compatibility | Biocompatible | Biocompatible | Equivalent |
| Use | Prescription/Hospital | Prescription/Hospital | Equivalent |
| Standards | ISO7405 | ISO7405 | Equivalent |

There are similarities between the subject device and predicate device.

The indications for use of the subject device and predicate device is above the comparison table. Also, the subject device has similar physical properties to the predicate device.

| Physical characteristics | Subject Device | Predicate Device |
|------------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity to ambient light | homogeneous | homogeneous |
| Depth of cure | More than 1.5mm | Light-cure with a polymerisation<br>light (minimum 500 mW/cm) a film<br>thickness up to 1 mm for 10s, (e.g.<br>in case of covering the gingival<br>margin), a thickness up to 5 mm for<br>20 s and more than 5mm for 40s. |

However, the composition of the subject device is slightly different from the predicate device. However, the main ingredients are similar. Also, the biocompatibility and performance tests were confirmed.

## 5.9 Conclusions

Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed devices identified in this submission.