(57 days)
Not Found
No
The device description and performance studies focus on the physical, chemical, and biological properties of a mineral root canal sealer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a root canal sealer that fills the root canal, which is a restorative rather than therapeutic function.
No
This device is a root canal sealer used for permanent root canal filling, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe" and is an "implantable medical device intended to be used in dentistry." This describes a physical substance and delivery mechanism, 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 permanent root canal filling in combination with gutta-percha points. This is a therapeutic procedure performed directly on the patient's tooth.
- Device Description: The device is described as a hydrophilic mineral root canal sealer used to seal the root canal. It is an "implantable medical device intended to be used in dentistry."
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on bodily specimens.
The device is a medical device used for a therapeutic purpose within the body (specifically, the root canal of a tooth).
N/A
Intended Use / Indications for Use
- 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.
Product codes
KIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal of the tooth
Indicated Patient Age Range
Permanent and mature teeth
Intended User / Care Setting
Dental healthcare professional.
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)
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, and from biological data, the biocompatibility profile of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g can be considered acceptable when used as intended.
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.
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.
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.
Not Found
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
§ 872.3820 Root canal filling resin.
(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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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
1
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, 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 331-49-76-71-16 Establishment Registration No: 9610964
Contact: Leslie Fillion, Regulatory Affairs Manager Contact Phone: 1-519-623-4800 Ext. 6354 Contact Email: Ifillion@septodont.com 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,
BioRoot™ Flow 2g
(Subject Device) | BioRoot™ RCS
(Primary Predicate
Device - K130601) | iRoot SP
(Secondary Predicate
Device - K080917) | Similarities and
Differences between
Subject Device and
Predicate Devices |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Septodont | Septodont | Innovative BioCeramix
Inc. | N/A |
| Classification
device code | KIF | KIF | KIF | Same; Substantially
Equivalent |
| Classification
Name | Resin, Root canal filling | Resin, Root canal
filling | Resin, Root canal
filling | Same; Substantially
Equivalent |
| Class | Class II | Class II | Class II | Same; Substantially
Equivalent |
| Intended
Use | Permanent root canal
sealer | Permanent root canal
sealer | Permanent root
canal sealer | Same, Substantially
Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g
(Subject Device) | BioRoot™ RCS
(Primary Predicate
Device - K130601) | iRoot SP
(Secondary Predicate
Device - K080917) | Similarities and
Differences between
Subject Device and
Predicate Devices |
| Indications | 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. | 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.
BioRoot™ RCS is
suitable for use in
single cone technique
or cold lateral
condensation. | Permanent obturation
of the root canal
following vital pulp-
extirpation.
Permanent obturation
of the root canal
following removal of
infected or
necrotic pulp and
placement of
intracanal dressings. | iRoot SP - Similar,
indications statement
does not mention gutta-
percha points
BioRoot™ RCS –
Similar, does not
include the statement
regarding being suitable
for use in single cone
technique or cold lateral
condensation (due to
the change in design,
obturation is no longer
limited to specific
techniques). |
| Intended
Users | Dental healthcare
professional. | Dental healthcare
professional. | Dental healthcare
professional. | Same, Substantially
Equivalent |
| Intended
Patient
Population | Permanent and mature
teeth | Permanent and mature
teeth | Permanent and
mature teeth | Same, Substantially
Equivalent |
| Prescription/
over-the-
counter use | Prescription | Prescription | Prescription | Same, Substantially
Equivalent |
| Single-use/
multiple use | Multi-Use Device (only
the tips are considered
single use) | Single Use Device
(The bottle of powder
is multi-use, whereas
the single dose
containers are single
use) | Multi-Use | iRoot SP - Same;
Substantially Equivalent |
| Galenic
Forms
(Delivery
System) | Paste
(paste syringe) | Powder/Liquid
(powder liquid mixing) | Paste
(paste syringe) | iRoot SP - Same;
Substantially Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g
(Subject Device) | BioRoot™ RCS
(Primary Predicate
Device - K130601) | iRoot SP
(Secondary Predicate
Device - K080917) | Similarities and
Differences between
Subject Device and
Predicate Devices |
| Ingredients
and
quantities | Paste (per 100g):
• Tricalcium silicate
(36.07g)
• Zirconium oxide
(30.00g)
• Calcium carbonate
(3.50g)
• Propylene glycol
(27.93g)
• Polyvidone K90
(1.00g)
• Sepineo P600
(1.00g)
• Aerosil R1812S
(0.50g) | Powder (per 100g):
• Tricalcium silicate -
Micronized C3S
(30.00g)
• Tricalcium silicate
(30.00g)
• Zirconium oxide
(35.00g)
• Polyvidone K90
(5.00g)
Liquid (per 100g):
• Dihydrated Calcium
Chloride (29.40g)
• Neomere Tech
(2.00g)
• Purified water
(68.60g) | Paste:
• Tricalcium silicate
• Dicalcium silicate
• Calcium
Phosphate
• Zirconium oxide
• Calcium hydroxide
• Solvent
• Gelifying Agent
• Stabilizer
Quantities are
unknown as this is
proprietary
information. | The ingredients
contained in
BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g and
iRoot SP are similar and
determined to be
substantially equivalent.
BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g
performance testing has
demonstrated
substantial equivalence
to BioRoot™ RCS.
BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g has
similar ingredients to
BioRoot™ RCS with a
few additional
ingredients to allow for
the paste. The
quantities also differ
between the two
devices however once
reconstituted the
cements have the same
amount of Tricalcium
silicate and Zirconium
oxide (approx. 66%)
indicating an equivalent
composition.
Performance reports
have demonstrated
substantial equivalence
(refer to Section 18). |
| Containers | Premixed paste is
contained in a syringe | Powder is packaged in
a capsule; liquid is
packaged in a single
dose container | Premixed paste is
contained in a
syringe | iRoot SP - Same;
Substantially Equivalent
BioRoot™ RCS -
Different; container
closure system is
different due to different
delivery system
iRoot SP - Same;
Substantially Equivalent |
| Operations
(Mixing and
Dispensing) | No mixing required,
product is a ready-to-
use paste | Mixing: liquid added to
powder and mixed by
hand by the dentist. | No mixing required,
product is a ready-to-
use paste | iRoot SP - Same;
Substantially Equivalent |
| Characteristic | BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g
(Subject Device) | BioRoot™ RCS
(Primary Predicate
Device - K130601) | iRoot SP
(Secondary Predicate
Device - K080917) | Similarities and
Differences between
Subject Device and
Predicate Devices |
| | | | | BioRoot™ RCS -
Different; mixing is
required as it requires
reconstitution of the
powder and liquid. |
| Consistency | Paste | Not Performed (not a
paste) | Paste | iRoot SP - Same;
Substantially Equivalent |
| Setting
Time | 1h to 6h | 55min to 300min | 4h | Performance testing
have demonstrated that
BioRoot™ Flow 0.5g,
BioRoot™ Flow 2g is
substantially equivalent
to BioRoot™ RCS and
iRoot SP sealer
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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