BioRoot Flow 0.5g, BioRoot Flow 2g

K212283 · Septodont · KIF · Sep 16, 2021 · Dental

Device Facts

• Record ID: K212283
• Device Name: BioRoot Flow 0.5g, BioRoot Flow 2g
• Applicant: Septodont
• Product Code: KIF · Dental
• Decision Date: Sep 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent root canal sealer.

Device Story

BioRoot Flow is a hydrophilic mineral root canal sealer supplied as a ready-to-use paste in a syringe. It utilizes a tricalcium silicate reaction with in situ water to seal the root canal. Used in dentistry by dental healthcare professionals in combination with gutta-percha points to fill root canals. The device ensures adaptation to the root canal, a tight interface with gutta-percha, and radiopacity. It is an implantable device intended for permanent root canal filling. The ready-to-use paste format eliminates the manual mixing required by previous powder/liquid systems, simplifying the clinical workflow for the dentist while maintaining equivalent chemical and physical performance to predicate sealers.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing (physical-chemical properties, setting time, sealing, adhesion) and biocompatibility testing (chemical characterization and toxicological risk assessment). Clinical performance is bridged to the primary predicate, BioRoot RCS, based on identical intended use, site of application, patient population, and mechanical/biological properties.

Technological Characteristics

Hydrophilic mineral-based paste. Composition: Tricalcium silicate, Zirconium oxide, Calcium carbonate, Propylene glycol, Polyvidone K90, Sepineo P600, Aerosil R1812S. Principle: Tricalcium silicate reaction with in situ water. Form factor: Syringe-delivered paste. Setting time: 1h to 6h. Non-sterile.

Indications for Use

Indicated for permanent root canal filling in combination with gutta-percha points in patients with inflamed or necrotic pulp, or following a retreatment procedure. For use in permanent and mature teeth by dental healthcare professionals.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• BioRoot RCS (K130601)
• iRoot SP (K080917)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 16, 2021

Septodont Greg Montgomery Business Operations Manager 205 Granite Run Drive, Suite 150 Lancaster, Pennsylvania 17601

Re: K212283

Trade/Device Name: BioRoot Flow 0.5g, BioRoot Flow 2g Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 19, 2021 Received: July 21, 2021

Dear Greg Montgomery:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

Sincerely,

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) K212283

Device Name BioRoot Flow 0.5g, BioRoot Flow 2g

#### Indications for Use (Describe)

- · Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp.
- · Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.

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

| <span> <b> <div style="display:inline-block; width:15px; height:15px;">☑</div> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <b> <div style="display:inline-block; width:15px; height:15px;">☐</div> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 5. 510(K) Summary K212283

#### Septodont BioRoot™ Flow 0.5q. BioRoot™ Flow 2q (per 21 CFR 807.93)

#### 1. SUBMITTER/510(K) HOLDER

Septodont 58, rue du Pont De Créteil Saint-Maur des Fossés Cedex Phone: [phone] Establishment Registration No: 9610964

Contact: Leslie Fillion, Regulatory Affairs Manager Contact Phone: [phone] Ext. 6354 Contact Email: [e-mail] Date Prepared: July 13, 2021

## 2. DEVICE NAME

BioRoot™ Flow 0.5g, BioRoot™ Flow 2g Device Name: Device Classification Name: Resin, Root Canal Filling/Dental Cement Regulation Number: Primary: 872.3820, Secondary: 872.3250 Classification Product Code: KIF Device Class: Class II

## 3. PREDICATE DEVICE

#### Primary Predicate

| Manufacturer: | Septodont |
|------------------------------|-----------------------------------------|
| Device Name: | BioRoot TM RCS |
| Device Classification Name: | Resin, Root Canal Filling/Dental Cement |
| 510(k) Number: | K130601 |
| Regulation Number: | Primary: 872.3820, Secondary: 872.3250 |
| Classification Product Code: | KIF |
| Device Class: | Class II |

#### Secondary Predicate

| Manufacturer: | Innovative BioCeramix Inc |
|------------------------------|-----------------------------------------|
| Device Name: | iRoot SP |
| Device Classification Name: | Resin, Root Canal Filling/Dental Cement |
| 510(k) Number: | K080917 |
| Regulation Number: | Primary: 872.3820, Secondary: 872.3250 |
| Classification Product Code: | KIF |
| Device Class: | Class II |

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## 4. DEVICE DESCRIPTION

BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity.

It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.

# 5. INDICATION FOR USE/INTENDED USE

The intended use for BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is:

- Permanent root canal sealer .
The indications for BioRoot™ Flow 0.5g, BioRoot™ Flow 2g are:

- Permanent root canal filling in combination with gutta-percha points in case of . inflamed or necrotic pulp.
- Permanent root canal filling in combination with gutta-percha points following . a retreatment procedure.

# 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

Septodont demonstrated that BioRoot™ Flow 0.5g. BioRoot™ Flow 2q is substantially equivalent to the predicate devices, BioRoot™ RCS (K130601, cleared 17-Oct-2013) and iRoot SP (K080917, cleared 09-Apr-2008), in regards to the indications and basic design principles. The indications, technological characteristics and overall design of the subject device are substantially equivalent to those of the predicate devices, with any differences limited to minor differences in design and performance that do not raise any new questions of safety or effectiveness.

# 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

BioRoot™ Flow 0.5g, BioRoot™ Flow 2g has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to the predicate devices, BioRoot™ RCS and iRoot SP. All three (3) devices are provided non-sterile, have comparable setting time, sealing and adhesion.

Biocompatibility test results determined that considering all existing data resulting from the chemical characterization and associated toxicological risk assessment.

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and from biological data, the biocompatibility profile of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g can be considered acceptable when used as intended.

## 8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Clinical equivalence between BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and the primary predicate, BioRoot™ RCS, was demonstrated based on equivalence in terms of the intended use, indications for use, technical, mechanical and biological properties. Furthermore, BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and BioRoot™ RCS are used for the same clinical indication, at the same site in the body (root canal of the tooth), are in contact with the same tissues (root canal dentine), in the same population (mature and permanent teeth) and have the same clinical performance in regards to the expected clinical effect for a specific intended purpose. Clinical evaluation data obtained using the equivalent device, BioRoot™ RCS, was used to support clinical evidence of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and can be extended to BioRoot™ Flow 0.5g, BioRoot™ Flow 2g in terms of clinical performance and clinical safety.

# 9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The subject device, BioRoot™ Flow 0.5g, BioRoot™ Flow 2g, and its' predicate devices, BioRoot™ RCS and iRoot SP, have demonstrated to be substantially equivalent and have comparable chemical, physical and performance specifications. Based on the above information and the data provided, the subject device has demonstrated to be substantially equivalent to both the primary predicate device, BioRoot™ RCS (K130601, cleared 17-Oct-2013), and the secondary predicate device, iRoot SP (K080917, cleared 09-Apr-2008).

| Characteristic | BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g<br>(Subject Device) | BioRoot™ RCS<br>(Primary Predicate<br>Device - K130601) | iRoot SP<br>(Secondary Predicate<br>Device - K080917) | Similarities and<br>Differences between<br>Subject Device and<br>Predicate Devices |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Septodont | Septodont | Innovative BioCeramix<br>Inc. | N/A |
| Classification<br>device code | KIF | KIF | KIF | Same; Substantially<br>Equivalent |
| Classification<br>Name | Resin, Root canal filling | Resin, Root canal<br>filling | Resin, Root canal<br>filling | Same; Substantially<br>Equivalent |
| Class | Class II | Class II | Class II | Same; Substantially<br>Equivalent |
| Intended<br>Use | Permanent root canal<br>sealer | Permanent root canal<br>sealer | Permanent root<br>canal sealer | Same, Substantially<br>Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g<br>(Subject Device) | BioRoot™ RCS<br>(Primary Predicate<br>Device - K130601) | iRoot SP<br>(Secondary Predicate<br>Device - K080917) | Similarities and<br>Differences between<br>Subject Device and<br>Predicate Devices |
| Indications | Permanent root canal<br>filling in combination<br>with gutta-percha points<br>in case of inflamed or<br>necrotic pulp.<br>Permanent root canal<br>filling in combination<br>with gutta-percha points<br>following a retreatment<br>procedure. | Permanent root canal<br>filling in combination<br>with gutta-percha<br>points in case of<br>inflamed or necrotic<br>pulp.<br>Permanent root canal<br>filling in combination<br>with gutta-percha<br>points following a<br>retreatment procedure.<br>BioRoot™ RCS is<br>suitable for use in<br>single cone technique<br>or cold lateral<br>condensation. | Permanent obturation<br>of the root canal<br>following vital pulp-<br>extirpation.<br>Permanent obturation<br>of the root canal<br>following removal of<br>infected or<br>necrotic pulp and<br>placement of<br>intracanal dressings. | iRoot SP - Similar,<br>indications statement<br>does not mention gutta-<br>percha points<br>BioRoot™ RCS –<br>Similar, does not<br>include the statement<br>regarding being suitable<br>for use in single cone<br>technique or cold lateral<br>condensation (due to<br>the change in design,<br>obturation is no longer<br>limited to specific<br>techniques). |
| Intended<br>Users | Dental healthcare<br>professional. | Dental healthcare<br>professional. | Dental healthcare<br>professional. | Same, Substantially<br>Equivalent |
| Intended<br>Patient<br>Population | Permanent and mature<br>teeth | Permanent and mature<br>teeth | Permanent and<br>mature teeth | Same, Substantially<br>Equivalent |
| Prescription/<br>over-the-<br>counter use | Prescription | Prescription | Prescription | Same, Substantially<br>Equivalent |
| Single-use/<br>multiple use | Multi-Use Device (only<br>the tips are considered<br>single use) | Single Use Device<br>(The bottle of powder<br>is multi-use, whereas<br>the single dose<br>containers are single<br>use) | Multi-Use | iRoot SP - Same;<br>Substantially Equivalent |
| Galenic<br>Forms<br>(Delivery<br>System) | Paste<br>(paste syringe) | Powder/Liquid<br>(powder liquid mixing) | Paste<br>(paste syringe) | iRoot SP - Same;<br>Substantially Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g<br>(Subject Device) | BioRoot™ RCS<br>(Primary Predicate<br>Device - K130601) | iRoot SP<br>(Secondary Predicate<br>Device - K080917) | Similarities and<br>Differences between<br>Subject Device and<br>Predicate Devices |
| Ingredients<br>and<br>quantities | Paste (per 100g):<br>• Tricalcium silicate<br>(36.07g)<br>• Zirconium oxide<br>(30.00g)<br>• Calcium carbonate<br>(3.50g)<br>• Propylene glycol<br>(27.93g)<br>• Polyvidone K90<br>(1.00g)<br>• Sepineo P600<br>(1.00g)<br>• Aerosil R1812S<br>(0.50g) | Powder (per 100g):<br>• Tricalcium silicate -<br>Micronized C3S<br>(30.00g)<br>• Tricalcium silicate<br>(30.00g)<br>• Zirconium oxide<br>(35.00g)<br>• Polyvidone K90<br>(5.00g)<br>Liquid (per 100g):<br>• Dihydrated Calcium<br>Chloride (29.40g)<br>• Neomere Tech<br>(2.00g)<br>• Purified water<br>(68.60g) | Paste:<br>• Tricalcium silicate<br>• Dicalcium silicate<br>• Calcium<br>Phosphate<br>• Zirconium oxide<br>• Calcium hydroxide<br>• Solvent<br>• Gelifying Agent<br>• Stabilizer<br>Quantities are<br>unknown as this is<br>proprietary<br>information. | The ingredients<br>contained in<br>BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g and<br>iRoot SP are similar and<br>determined to be<br>substantially equivalent.<br>BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g<br>performance testing has<br>demonstrated<br>substantial equivalence<br>to BioRoot™ RCS.<br>BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g has<br>similar ingredients to<br>BioRoot™ RCS with a<br>few additional<br>ingredients to allow for<br>the paste. The<br>quantities also differ<br>between the two<br>devices however once<br>reconstituted the<br>cements have the same<br>amount of Tricalcium<br>silicate and Zirconium<br>oxide (approx. 66%)<br>indicating an equivalent<br>composition.<br>Performance reports<br>have demonstrated<br>substantial equivalence<br>(refer to Section 18). |
| Containers | Premixed paste is<br>contained in a syringe | Powder is packaged in<br>a capsule; liquid is<br>packaged in a single<br>dose container | Premixed paste is<br>contained in a<br>syringe | iRoot SP - Same;<br>Substantially Equivalent<br>BioRoot™ RCS -<br>Different; container<br>closure system is<br>different due to different<br>delivery system<br>iRoot SP - Same;<br>Substantially Equivalent |
| Operations<br>(Mixing and<br>Dispensing) | No mixing required,<br>product is a ready-to-<br>use paste | Mixing: liquid added to<br>powder and mixed by<br>hand by the dentist. | No mixing required,<br>product is a ready-to-<br>use paste | iRoot SP - Same;<br>Substantially Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g<br>(Subject Device) | BioRoot™ RCS<br>(Primary Predicate<br>Device - K130601) | iRoot SP<br>(Secondary Predicate<br>Device - K080917) | Similarities and<br>Differences between<br>Subject Device and<br>Predicate Devices |
| | | | | BioRoot™ RCS -<br>Different; mixing is<br>required as it requires<br>reconstitution of the<br>powder and liquid. |
| Consistency | Paste | Not Performed (not a<br>paste) | Paste | iRoot SP - Same;<br>Substantially Equivalent |
| Setting<br>Time | 1h to 6h | 55min to 300min | 4h | Performance testing<br>have demonstrated that<br>BioRoot™ Flow 0.5g,<br>BioRoot™ Flow 2g is<br>substantially equivalent<br>to BioRoot™ RCS and<br>iRoot SP sealer<br>regarding setting time. |

## Side-by-Side Comparison of BioRoot™ Flow 0.5q, BioRoot™ Flow 2q with BioRoot™RCS and iRoot SP

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