(61 days)
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;
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.
The provided FDA 510(k) summary for Biodentine™ XP 500, Biodentine™ XP 200 describes a non-clinical study to demonstrate substantial equivalence to a predicate device, Biodentine™ (K140132). This submission does not include information about an AI/ML powered device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets the criteria in the context of an AI/ML device. The document explicitly states:
"No clinical data was collected using Biodentine™ XP 500. Biodentine™ XP 200 to support substantial equivalence between the subject and the predicate devices."
Instead, the submission relies on non-clinical (bench) testing and biological equivalence to the predicate device to demonstrate substantial equivalence.
Here's a summary of the non-clinical performance as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or target value format for each characteristic as it's a comparison to a predicate device. Instead, it compares the subject device's performance to the predicate device's performance, aiming for "Same" or "Similar" results.
| Characteristic | Subject: Biodentine™ XP 500, Biodentine™ XP 200 Reported Performance | Predicate: Biodentine™ Reported Performance | Comparison (Acceptance) |
|---|---|---|---|
| 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 |
| Aspect | Comparable to predicate | - | Comparable |
| pH | Comparable to predicate | - | Comparable |
| Porosity | Comparable to predicate | - | Comparable |
| Hardness | Comparable to predicate | - | Comparable |
| Radiopacity | Comparable to predicate | - | Comparable |
| Sealing ability | Comparable to predicate | - | Comparable |
| Biological equivalence (mutagenicity, sensitizer, irritant, systemic toxicity, biocompatibility, bioactivity) | Not mutagenic, sensitizer, or irritant; does not induce systemic toxicity; fully biocompatible and equally bioactive (induces mineralization processes) | Based on Biodentine™ biocompatibility data | Biologically equivalent |
| Shelf-life | Equivalent to predicate device | - | Equivalent |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "extensive bench testing" and "biological equivalence demonstrated."
- Data Provenance: Not explicitly stated. The testing was conducted to compare the Biodentine™ XP 500/200 to the Biodentine™ predicate device, presumably by the manufacturer, Septodont.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission, as it's a non-clinical, bench testing-based equivalence study, not a clinical study involving expert interpretation for ground truth.
4. Adjudication method for the test set:
Not applicable, as this was not a clinical study with image interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device, and no MRMC study was conducted. The document explicitly states "No clinical data was collected."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" or reference was likely established through standardized physical, chemical, and biological testing methods (e.g., ISO standards for dental materials) to measure properties like working time, setting time, compressive strength, pH, porosity, hardness, radiopacity, and biocompatibility. The performance of the predicate device also served as a reference for comparison.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, and no training set was used.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
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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
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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 (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™ XP500,Biodentine™ XP200 | 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 (childrenfrom 2 years of age) and | In the crown: | Similar | |
| Characteristic | Subject:Biodentine™ XP500,Biodentine™ XP200 | Predicate:Biodentine™(K140132;cleared on 2014 June 27th) | Comparison(Same,Similar,Different) | |
| permanent teeth (immatureor mature)- Permanent dentinerestoration undercomposites or Inlay/Onlay- Temporary dentine-enamel restoration- Restoration of deepand/or large coronalcarious lesions (sandwichtechnique).- Restoration of cervicalor radicular lesions | -Permanent dentinerestoration under compositesor Inlay/Onlay-Temporary dentine-enamelrestoration.-Restoration of deep and/orlarge coronal carious lesions(sandwich technique).-Restoration of cervicalradicular lesions. | |||
| On the pulp:For temporary teeth (childrenfrom 2 years of age) andpermanent teeth (immatureor mature)- Pulp capping (direct andindirect)- Pulpotomy for diagnosedsymptoms of reversiblepulpitis and irreversiblepulpitis where bleeding iscontrolled within 5minutes | -Pulp capping.-Pulpotomy. | Similar | ||
| In the root:For permanent teeth(immature or mature)- Repair of root perforations.- Repair of furcationperforations- Repair of perforatinginternal resorptions- Repair of externalresorption- Root-end filling inendodontic surgery(retrograde filling) | In the root:- Repair of root perforations.- Repair of furcationperforations.- Repair of perforatinginternal resorptions.- Repair of externalresorption- Root-end filling inendodontic surgery(retrograde filling). | Similar | ||
| Characteristic | Subject:Biodentine™ XP500,Biodentine™ XP200 | Predicate:Biodentine™(K140132;cleared on 2014 June 27th) | Comparison(Same,Similar,Different) | |
| For immature permanentteeth:- Apexification | - Apexification. | |||
| User population | Biodentine™ XP 500,Biodentine™ XP 200 isintendedto be applied ontemporary teeth (from 2years old), on permanentteeth (mature or immature)or on non-vital immaturepermanent teethdepending on indication. | Information not provided inBiodentine™ label submittedin K140132. | Similar;User populationinformation inlabel is nowrequired for allSeptodont'sproduct | |
| Prescription/ over-the- | Prescription | Prescription | Same | |
| counter useSingle-use /multiple use | Single use | Single use | Same | |
| Galenic Forms | Powder/Liquid | Powder/Liquid | Same | |
| Ingredients | Powder: tricalcium silicate,zirconium oxide, calciumoxide, calcium carbonate,iron-oxide based pigmentsLiquid: calcium chloride,polycarboxylate, purifiedwater | Powder: tricalcium silicate,zirconium oxide, calciumoxide, calcium carbonate,iron-oxide based pigmentsLiquid: calcium chloride,polycarboxylate, purifiedwater | Same | |
| Ingredients quantity | ||||
| XP500:Powder: 700mgLiquid: 190µLXP200 :Powder: 450mgLiquid: 122µL | Capsule of powder : 700mgSingle-dose container ofliquid : 250µLThe dental healthcareprofessional put 5 or 6 dropsinto the capsule powder i.e173µL to 208µL | Similar; ratiopowder/liquid(w/w) isequivalent forsubject device(XP500 (3.04)and XP200(2.91))compared topredicatedevice(between 2.79and 3.34). | ||
| Liquid formulation | In XP200 and XP500formulation:For 100 g quantity:Plasticizer: 0.5 gPurified water: 70.10 g | For 100 g quantity:Plasticizer: 2.0 gPurified water: 68.60 g | Similar;BiodentineTMXP liquidformulation issimilar toBiodentineTMliquid formulation. | |
| Characteristic | Subject:BiodentineTM XP500,BiodentineTM XP200 | Predicate:BiodentineTM(K140132;cleared on 2014 June 27th) | Comparison(Same,Similar,Different) | |
| The ingredientsare the samebut the quantityfor theplasticizeragent and thepurified waterare differentfrom thepredicate.Performanceequivalence hasbeendemonstratedon subject andpredicatefinishedproductsdemonstratingthat thedifference inplasticizerquantity in theliquidformulationdoes not impactproductspecificationswhen comparedsubject device(XP500 andXP200) topredicatedevice. | ||||
| Containers | Powder and liquid arepackaged in the all-in-oneBiodentine™ XP 500,Biodentine™ XP 200single-dose cartridge | Powder in capsuleLiquid in single-dosecontainer | Different;however,stability resultsobtained forsubject deviceprovideequivalent shelflife than the | |
| Characteristic | Subject:Biodentine™ XP500,Biodentine™ XP200 | Predicate:Biodentine™(K140132;cleared on 2014 June 27th) | Comparison(Same,Similar,Different) | |
| predicatedevice.Human factorstudy hasprovidedevidence ofsafety andeffectivenessfor the subjectdevice. | ||||
| Mixing and Dispensing | Mixing: using theBiodentineTM MixerDispensing: using theBiodentineTM Gun dispenserby the dental healthcarespecialist | Mixing: using a mixerDispensing: Manually by thedental healthcare specialist | Same formixing step.Different forthe dispensingstep, howeverhuman factorstudy hasprovidedevidence ofsafety andeffectivenessfor the subjectdevice. | |
| Working Time | ≥ 1min | ≥ 1min | Same | |
| Setting Time (at 37°C) | 9 to 25 min(average time of 12.5minutes) | 9 to 25 min(average time of 12.5minutes) | Same | |
| Compressive strength | ≥ 150 MPA at 24h | ≥ 150 MPA at 24h | Same |
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§ 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.