(61 days)
No
The 510(k) summary describes a bioactive dentin substitute material and associated mixing/dispensing accessories. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies focus on material properties and biological equivalence to a predicate device.
Yes
The device is used for restoration under composites, temporary dentine-enamel restoration, restoration of carious lesions, restoration of cervical or radicular lesions, pulp capping, pulpotomy, repair of root and furcation perforations, repair of internal and external resorptions, root-end filling, and apexification, all of which are considered therapeutic interventions in dentistry.
No
The device, Biodentine™ XP 500/200, is described as a "bioactive dentin substitute" used for restorative and repair procedures in teeth, such as dentine restoration, pulp capping, and root repair. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "bioactive dentin substitute" prepared from a powder and liquid mixture, presented in a cartridge, and used with a mixer and gun. This describes a physical material and associated hardware, 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 describes a material used for dental restoration and repair within the tooth structure (crown, pulp, root). This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The device is described as a "bioactive dentin substitute" and a "mixture of a powder and a liquid." This is consistent with a material used for filling or repairing tissue, not for analyzing samples from the human body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The anatomical site is the tooth, which is where the material is applied directly for treatment. IVDs typically interact with samples taken from the body.
In summary, the device's function is to physically repair and restore dental tissue, which falls under the category of a medical device for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use
In the crown:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
-
Permanent dentine restoration under composites or Inlay/Onlay
-
Temporary dentine-enamel restoration;
-
Restoration of deep and/or large coronal carious lesions (sandwich technique);
-
Restoration of cervical or radicular lesions.
On the pulp:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Pulp capping (direct and indirect).
- Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes.
In the root:
For permanent teeth (immature or mature):
- Repair of root perforations;
- Repair of furcation perforations;
- Repair of perforating internal resorptions;
- Repair of external resorption;
- Root-end filling in endodontic surgery (retrograde filling).
For immature permanent teeth
- Apexification;
Product codes
KIF
Device Description
Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed.
The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Crown, pulp, root, dentine, enamel
Indicated Patient Age Range
Children from 2 years of age, immature or mature permanent teeth
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)
Biodentine™ XP 500, Biodentine™ XP 200 have undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to the Biodentine™ predicate device. Both devices are providednon-sterile, have comparable aspect, working time, setting time, compressive strength, sealing ability, pH, porosity, u hardness and radiopacity.
Biological equivalence has been demonstrated between the subject device, Biodentine™ XP 500, Biodentine™ XP 200 and predicate device, Biodentine™ allowing Septodont to conclude based on Biodentine™ biocompatibilitydata, that Biodentine™ XP 500, Biodentine™ XP 200 is not mutagenic nor a sensitizer or irritant and does not induce any systemic toxicity. It is considered as fully biocompatible and equally bioactive as it is able to induce the mineralization processes.
No clinical data was collected using Biodentine™ XP 500. Biodentine™ XP 200 to support substantial equivalence between the subject and the predicate devices. Clinical equivalence between the two devices has been demonstrated based on the equivalence demonstration in terms of intended use/indications for use, physico- mechanical, chemical, bioactivity and biological properties.
Furthermore, devices are used for the same clinical condition, including similar severity and stage of disease, at the same site in the body (crown, pulp or root of the tooth), in contact with the same tissues (enamel, dentine, pulp), in same population (adult and pediations from 2 years age) and has same relevant critical performance in view of the expected clinical effect for a specific intended purpose. Consequently, the use of the clinical evaluation data obtained using the Biodentine™ is sufficient to demonstrate clinical conformity for the Biodentine™ XP 500, Biodentine™ XP 200.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
August 10, 2021
Septodont Greg Montgomery Business Operations Manager 205 Granite Run Drive, Suite 150 Lancaster, Pennsylvania 17601
Re: K211799
Trade/Device Name: Biodentine XP 500, Biodentine XP 200 Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: June 4, 2021 Received: June 10, 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) K211799
Device Name Biodentine XP 500, Biodentine XP 200
Indications for Use (Describe)
In the crown:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
-
Permanent dentine restoration under composites or Inlay/Onlay
-
Temporary dentine-enamel restoration;
-
Restoration of deep and/or large coronal carious lesions (sandwich technique);
-
Restoration of cervical or radicular lesions.
On the pulp:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Pulp capping (direct and indirect).
- Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes.
In the root:
For permanent teeth (immature or mature):
- Repair of root perforations;
- Repair of furcation perforations;
- Repair of perforating internal resorptions;
- Repair of external resorption;
- Root-end filling in endodontic surgery (retrograde filling).
For immature permanent teeth
- Apexification;
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. 510(K) SUMMARY
K211799
Septodont Biodentine™ XP 500, Biodentine™ XP 200 (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
Septodont
58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés, Cedex France
Phone: 331-49-76-71-16 Establishment Registration No: 9610964 Contact: Leslie Fillion, Regulatory Affairs Manager Contact Phone: +1-(519)-623-4800, x6354 Contact Email: lfillion(@septodont.com Date Prepared: 08/09/2021
2. DEVICE NAME
| Device Name: | Biodentine™ XP 500, Biodentine™ XP 200 |
|---|---|
| Device Classification Name: | Resin, Root Canal Filling/Liner, Cavity, Calcium Hydroxide |
| Regulation Number: | primary : 872.3820 |
| Classification Product Code: | primary: KIF |
| Device Class: | II |
3. PREDICATE DEVICE
| Manufacturer: | Septodont |
|---|---|
| Device Name: | BiodentineTM |
| Device Classification Name: | Resin, Root Canal Filling/Liner, Cavity, Calcium Hydroxide |
| 510(k) Number: | K140132 |
| Regulation Number: | primary: 872.3820, secondary: 872.3275 |
| Classification Product Code: | primary: KIF, secondary: EMA |
| Device Class: | II |
4. DEVICE DESCRIPTION
Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed.
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The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun.
5. INTENDED USE
Bioactive dentin substitute.
6. INDICATIONS FOR USE
In the crown:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Permanent dentine restoration under composites or Inlav/Onlav
- Temporary dentine-enamel restoration;
- Restoration of deep and/or large coronal carious lesions (sandwich technique);
- Restoration of cervical or radicular lesions.
On the pulp:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Pulp capping (direct and indirect).
- Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes.
In the root:
For permanent teeth (immature or mature):
- Repair of root perforations;
- Repair of furcation perforations;
- Repair of perforating internal resorptions;
- Repair of external resorption:
- Root-end filling in endodontic surgery (retrograde filling).
For immature permanent teeth
- Apexification:
7. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
Septodont demonstrated that, Biodentine™ XP 500, Biodentine™ XP 200 is substantially equivalent in indications and design principles to its predicate device, Septodont's Biodentine™ device, K140132 (cleared on June 27th 2014). The subject device and the predicate device have intended used, similar indication for use, same technological characteristics and are made of same materials.
Any differences in their methods of application do not raise any new issues of safety or efficacy for the Biodentine™ XP 500, Biodentine™ XP 200 device.
8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
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Biodentine™ XP 500, Biodentine™ XP 200 have undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to the Biodentine™ predicate device. Both devices are providednon-sterile, have comparable aspect, working time, setting time, compressive strength, sealing ability, pH, porosity, u hardness and radiopacity.
Biological equivalence has been demonstrated between the subject device, Biodentine™ XP 500, Biodentine™ XP 200 and predicate device, Biodentine™ allowing Septodont to conclude based on Biodentine™ biocompatibilitydata, that Biodentine™ XP 500, Biodentine™ XP 200 is not mutagenic nor a sensitizer or irritant and does not induce any systemic toxicity. It is considered as fully biocompatible and equally bioactive as it is able to induce the mineralization processes.
9. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical data was collected using Biodentine™ XP 500. Biodentine™ XP 200 to support substantial equivalence between the subject and the predicate devices. Clinical equivalence between the two devices has been demonstrated based on the equivalence demonstration in terms of intended use/indications for use, physico- mechanical, chemical, bioactivity and biological properties.
Furthermore, devices are used for the same clinical condition, including similar severity and stage of disease, at the same site in the body (crown, pulp or root of the tooth), in contact with the same tissues (enamel, dentine, pulp), in same population (adult and pediations from 2 years age) and has same relevant critical performance in view of the expected clinical effect for a specific intended purpose. Consequently, the use of the clinical evaluation data obtained using the Biodentine™ is sufficient to demonstrate clinical conformity for the Biodentine™ XP 500, Biodentine™ XP 200.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The subject device, Biodentine™ XP 500, Biodentine™ XP 200 and its predicate device Biodentine™ are designated for equivalentbioactive dentin substitute and have comparable chemical, physical and performance specifications. Both products have equivalent shelf-life. Based on the above information and data provided in this submission, the subject device has been demonstrated to be substantially equivalent to Septodont's cleared device, Biodentine™ (K140132, cleared on 06-27-2014).
| Table 5-1. Side-by-Side Comparison of Biodentine™ XP 500, Biodentine™ XP 200 with | ||||||
|---|---|---|---|---|---|---|
| Predicate Device Biodentine™. |
| Characteristic | Subject:
Biodentine™ XP
500,
Biodentine™ XP
200 | Predicate:
Biodentine™(K140132;
cleared on 2014 June 27th) | Comparison
(Same,
Similar,
Different) | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Septodont | Septodont | Same | |
| Classification device code | KIF | KIF / EMA | Same | |
| Classification Name | Resin, Root canal filling | Resin, Root canal filling | Same | |
| Class | Class II | Class II | Same | |
| Intended Use | Bioactive dentine substitute | Bioactive dentine substitute | Same | |
| Indications | In the crown:
For temporary teeth (children
from 2 years of age) and | In the crown: | Similar | |
| Characteristic | Subject:
Biodentine™ XP
500,
Biodentine™ XP
200 | Predicate:
Biodentine™(K140132;
cleared on 2014 June 27th) | Comparison
(Same,
Similar,
Different) | |
| | permanent teeth (immature
or mature)
- Permanent dentine
restoration under
composites or Inlay/Onlay - Temporary dentine-
enamel restoration - Restoration of deep
and/or large coronal
carious lesions (sandwich
technique). - Restoration of cervical
or radicular lesions | -Permanent dentine
restoration under composites
or Inlay/Onlay
-Temporary dentine-enamel
restoration.
-Restoration of deep and/or
large coronal carious lesions
(sandwich technique).
-Restoration of cervical
radicular lesions. | | |
| | On the pulp:
For temporary teeth (children
from 2 years of age) and
permanent teeth (immature
or mature) - Pulp capping (direct and
indirect) - Pulpotomy for diagnosed
symptoms of reversible
pulpitis and irreversible
pulpitis where bleeding is
controlled within 5
minutes | -Pulp capping.
-Pulpotomy. | Similar | |
| | In the root:
For permanent teeth
(immature or mature) - Repair of root perforations.
- Repair of furcation
perforations - Repair of perforating
internal resorptions - Repair of external
resorption - Root-end filling in
endodontic surgery
(retrograde filling) | In the root: - Repair of root perforations.
- Repair of furcation
perforations. - Repair of perforating
internal resorptions. - Repair of external
resorption - Root-end filling in
endodontic surgery
(retrograde filling). | Similar | |
| Characteristic | Subject:
Biodentine™ XP
500,
Biodentine™ XP
200 | Predicate:
Biodentine™(K140132;
cleared on 2014 June 27th) | Comparison
(Same,
Similar,
Different) | |
| | For immature permanent
teeth: - Apexification | - Apexification. | | |
| User population | Biodentine™ XP 500,
Biodentine™ XP 200 is
intendedto be applied on
temporary teeth (from 2
years old), on permanent
teeth (mature or immature)
or on non-vital immature
permanent teeth
depending on indication. | Information not provided in
Biodentine™ label submitted
in K140132. | Similar;
User population
information in
label is now
required for all
Septodont's
product | |
| Prescription/ over-the- | Prescription | Prescription | Same | |
| counter use
Single-use /multiple use | Single use | Single use | Same | |
| Galenic Forms | Powder/Liquid | Powder/Liquid | Same | |
| Ingredients | Powder: tricalcium silicate,
zirconium oxide, calcium
oxide, calcium carbonate,
iron-oxide based pigments
Liquid: calcium chloride,
polycarboxylate, purified
water | Powder: tricalcium silicate,
zirconium oxide, calcium
oxide, calcium carbonate,
iron-oxide based pigments
Liquid: calcium chloride,
polycarboxylate, purified
water | Same | |
| Ingredients quantity | | | | |
| | XP500:
Powder: 700mg
Liquid: 190µL
XP200 :
Powder: 450mg
Liquid: 122µL | Capsule of powder : 700mg
Single-dose container of
liquid : 250µL
The dental healthcare
professional put 5 or 6 drops
into the capsule powder i.e
173µL to 208µL | Similar; ratio
powder/liquid
(w/w) is
equivalent for
subject device
(XP500 (3.04)
and XP200
(2.91))
compared to
predicate
device
(between 2.79
and 3.34). | |
| Liquid formulation | In XP200 and XP500
formulation:
For 100 g quantity:
Plasticizer: 0.5 g
Purified water: 70.10 g | For 100 g quantity:
Plasticizer: 2.0 g
Purified water: 68.60 g | Similar;
BiodentineTM
XP liquid
formulation is
similar to
BiodentineTMliq
uid formulation. | |
| Characteristic | Subject:
BiodentineTM XP
500,
BiodentineTM XP
200 | Predicate:
BiodentineTM(K140132;
cleared on 2014 June 27th) | Comparison
(Same,
Similar,
Different) | |
| | | | | The ingredients
are the same
but the quantity
for the
plasticizer
agent and the
purified water
are different
from the
predicate.
Performance
equivalence has
been
demonstrated
on subject and
predicate
finished
products
demonstrating
that the
difference in
plasticizer
quantity in the
liquid
formulation
does not impact
product
specifications
when compared
subject device
(XP500 and
XP200) to
predicate
device. |
| Containers | Powder and liquid are
packaged in the all-in-one
Biodentine™ XP 500,
Biodentine™ XP 200
single-dose cartridge | Powder in capsule
Liquid in single-dose
container | Different;
however,
stability results
obtained for
subject device
provide
equivalent shelf
life than the | |
| Characteristic | Subject:
Biodentine™ XP
500,
Biodentine™ XP
200 | Predicate:
Biodentine™(K140132;
cleared on 2014 June 27th) | Comparison
(Same,
Similar,
Different) | |
| | | | | |
| | | | predicate
device.
Human factor
study has
provided
evidence of
safety and
effectiveness
for the subject
device. | |
| Mixing and Dispensing | Mixing: using the
BiodentineTM Mixer
Dispensing: using the
BiodentineTM Gun dispenser
by the dental healthcare
specialist | Mixing: using a mixer
Dispensing: Manually by the
dental healthcare specialist | Same for
mixing step.
Different for
the dispensing
step, however
human factor
study has
provided
evidence of
safety and
effectiveness
for the subject
device. | |
| Working Time | ≥ 1min | ≥ 1min | Same | |
| Setting Time (at 37°C) | 9 to 25 min
(average time of 12.5
minutes) | 9 to 25 min
(average time of 12.5
minutes) | Same | |
| Compressive strength | ≥ 150 MPA at 24h | ≥ 150 MPA at 24h | Same | |
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