(114 days)
No
The summary describes a calcium hydroxide paste for dental procedures and does not mention any AI or ML components or functionalities.
Yes
The device is a paste used for various dental treatments such as root canal dressings, apexification, pulp capping, and root resorption, which are all therapeutic interventions aimed at treating or preventing diseases.
No
The device is a calcium hydroxide paste used for various dental treatments to address issues such as root canal dressing, apexification, pulp capping, and root canal filling. Its function is to treat and fill, not to diagnose conditions.
No
The device description clearly states it is a "paste," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (temporary dressing for root canals, apexification, pulpotomy, pulp capping, root resorption, root canal filling) are all procedures performed directly on the patient's body within the oral cavity.
- Device Description: The description of a "premixed paste for direct application" further supports its use as a material applied within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, UltraCal XS calcium hydroxide paste is a dental material used for therapeutic and restorative purposes within the patient's mouth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
UltraCal XS calcium hydroxide paste is indicated to be used for:
· temporary dressing for root canals
- apexification and/or perforation
- · vital pulpotomy
- direct pulp capping
- · indirect pulp capping
- · root resorption
- root canal filling for primary teeth
Product codes (comma separated list FDA assigned to the subject device)
KIF, EJK
Device Description
UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canals (dental)
Indicated Patient Age Range
Individuals of all ages and gender and shall be assessed by the administering dental professional.
Intended User / Care Setting
Licensed Dentist or Dental 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)
The subject device successfully passed all verification and validation testing, including the biocompatibility assessment (ISO 7405:2018).
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.
DiaPaste (K210333)
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.
CleaniCal (K201799), TheraCal DC (K180344), Dia-Root Bio MTA (K200174)
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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October 13, 2021
Ultradent Products, Inc. Adam Black Regulatory Affairs Manager 505 West Ultradent Drive (10200 South) South Jordan, Utah 84095
Re: K211905
Trade/Device Name: UltraCal XS Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EJK Dated: July 15, 2021 Received: July 16, 2021
Dear Adam Black:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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) K211905
Device Name UltraCal XS
Indications for Use (Describe)
UltraCal XS calcium hydroxide paste is indicated to be used for:
· temporary dressing for root canals
- apexification and/or perforation
- · vital pulpotomy
- direct pulp capping
- · indirect pulp capping
- · root resorption
- root canal filling for primary teeth
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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510(k) Summary-K211905
This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for UltraCal XS.
l. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Mr. Adam Black |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 801-553-4425 |
| Cell Phone: | 435-459-9302 |
| Fax: | 801-553-4609 |
Date Summary Prepared: 22 September 2021
II. Name of the Device
| Device: | Resin, Root Canal Filling |
|---|---|
| Trade/Device Name: | UltraCal XS |
| Common Name: | Root Canal Filling Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Device Class: | Class II |
| Classification Product Code: | KIF |
| Subsequent Product Code: | EJK |
III. Device Description
UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.
IV. Statement of Intended Use
UltraCal XS calcium hydroxide paste is indicated to be used for:
- . Temporary dressing for root canals
- . Apexification and/or perforation
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- Vital Pulpotomy
- Direct Pulp Capping
- Indirect Pulp Capping
- Root resorption
- Root canal filling for primary teeth
V. Predicate Device
UltraCal XS identified primary predicate: DiaPaste (K210333); secondary predicates: CleaniCal (K201799), TheraCal DC (K180344), Dia-Root Bio MTA (K200174).
VII. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of UltraCal XS are substantially equivalent to the identified predicate as outlined in Table 5-1:
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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
Table 5-1: UltraCal XS substantial equivalence comparison
| Descriptive
Information/
characteristic | Primary Predicate:
DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:
CleaniCal (K201799) | Secondary Predicate:
TheraCal DC (K180344) | Secondary Predicate:
Dia-Root Bio MTA
(K200174) | Differences |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KIF | KIF, EJK | EJK, KIF | EJK | KIF | Similar |
| Intended Use | Aqueous ointment
material that
temporarily fills the
root canal for the
following indications:
-Apexification
-Temporary root filling
-Root canal filling for
primary teeth
-Vital pulpotomy
-Temporary pulp
capping | UltraCal XS calcium
hydroxide paste is
indicated to be used
for:
•Temporary dressing
for root canals
•Apexification and/or
perforation
•Vital Pulpotomy
•Direct Pulp Capping
•Indirect Pulp Capping
•Root resorption
•Root canal filling for
primary teeth | CleaniCal is a Calcium
Hydroxide paste that
has a creamy
consistency and is
suitable for several
indications including.
-Temporary
disinfectant dressings
in the obturation of
root canals
-Indirect pulp capping
or management of
deep caries lesions; or
-Direct pulp capping | 1. Pulpotomy
2. Temporary Filling
Material
3. Repair of Root
Perforations
4. Repair of Furcation
Perforations
5. Repair of Perforating
Internal and External
Resorptions
6. Root-End Filling in
Endodontic Surgery
7. Pulp Exposures (Direct
Pulp Capping)
8. Protective Liner
(Indirect Pulp Capping)
and Base for Use Under
a Variety of Substrates | DIA-ROOT BIO MTA is
used for pulp capping
(direct pulp capping or
partial pulpotomy) and
repair of root perforation.
Other indications for use
include: repair of root
resorption, root end
filling, apexification and
pulpotomy. | Similar
The Indications for Use
of the subject device is
within that of the
predicate and
reference device(s). |
| Intended User | Licensed Dentist or
Dental Professional | Licensed Dentist or
Dental Professional | Dental Professional | Dental Professional | Dental Professional | Identical |
| Characteristics | Calcium hydroxide
paste with barium
sulfate, used as a | Aqueous 12.0 to 12.5
pH calcium hydroxide,
radiopaque, premixed | Pre-filled syringe with
calcium hydroxide
paste with a pH of 12.3. | TheraCal DC is a
biocompatible, basic,
dual-cured, resin- | | Similar
The subject device as
well as the predicate |
| Descriptive
Information/
characteristic | Primary Predicate:
DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:
CleaniCal (K201799) | Secondary Predicate:
TheraCal DC (K180344) | Secondary Predicate:
Dia-Root Bio MTA
(K200174) | Differences |
| | temporary root canal
filling material. | paste for direct
application. | | modified calcium silicate
provided in a pre-filled
syringe | | and reference device(s)
are both calcium
hydroxide paste with
relatively high pH. |
| Composition | -Calcium Hydroxide
-Titanium Dioxide
-Zinc Oxide
-Barium Sulfate
-Water
-Polyether Polyol
-Polysorbate
(Tween80) | -Calcium hydroxide
-Water
-Barium Sulfate
-Propylene Glycol
-Hydroxypropyl
Methylcellulose | -Calcium hydroxide
-Zirconium dioxide
- Excipients (nMethyl-2-
pyrrolidone,
Hypromellose) | -Calcium hydroxide
-Portland Cement
-All other components
are proprietary | -Calcium silicate
-Zirconium dioxide
-Citric Acid
-Silanamine, 1,1,1-
trimethyl-N-
(trimethylsilyl-,hydrolysis
products with silica
-Hydroxypropyl
methylcellulose | Similar
The primary ingredient
is equivalent in the
predicate and subject
device, calcium
hydroxide. Barium
sulfate is included in
both as a radio-
opacifier. Differences in
the ingredients
included varying
chemicals used as
thickeners,
humectants,
emulsifiers, etc.
Dia-Root Bio MTA does
not include calcium
hydroxide as a
component, however
the hydration reaction
during setting occurs
between tricalcium |
| Descriptive
Information/
characteristic | Primary Predicate:
DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:
CleaniCal (K201799) | Secondary Predicate:
TheraCal DC (K180344) | Secondary Predicate:
Dia-Root Bio MTA
(K200174) | Differences |
| | | | | | | silicate $(3CaO·SiO2)$ and
dicalcium silicate
$(2CaO·SiO2)$ to form a
calcium hydroxide and
calcium silicate hydrate
gel, producing an
alkaline pH. |
| Delivery System
or Deployment
Methods | Product is provided in
a 2g syringe with
disposable delivery
tips | Product is provided in
a 1.2mL syringe with
disposable delivery
tips | Pre-loaded syringe | Pre-loaded syringe | Powder within a cap &
body to be mixed with
distilled water on a
mixing pad and applied
intraorally with a spatula | Similar
Both the subject device
and the predicate and
reference devices are
provided in a pre-filled
syringe with or without
delivery tips.
The difference with
Dia-Root Bio MTA
delivery is based on the
necessary reaction with
water to achieve
performance. |
| Descriptive
Information/
characteristic | Primary Predicate:
DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:
CleaniCal (K201799) | Secondary Predicate:
TheraCal DC (K180344) | Secondary Predicate:
Dia-Root Bio MTA
(K200174) | Differences |
| Physical
Properties | Confirmed to ISO 6876
-Flowability
-Film Thickness
-Radio-opacity | -Viscosity
-Water Removal
-Radio-Opacity | Confirmed to ISO 6876
-Packaging
-Extraneous matter
-Flowability
-Radio-opacity | Confirmed to ISO 6876
-Radiopaque
-Calcium releasing
-Basic
-Water sorption
-Solubility | Confirmed to ISO 6876
-Setting time
-Solubility
-Radiopacity | Similar
ISO 6876 is applicable
for root canal sealing
material, as UltraCal XS
is not intended to seal
root canals and was
therefore deemed not
applicable. Similar
testing was performed
to evaluate the
characteristics of the
chemistry. |
| Calcium
Hydroxide
Concentration | 22-26% | 35% | 30% | Not specified | Not specified - based on
ratio of distilled water
and calcium silicate used | Similar
Concentration range is
within ranges cleared
by FDA and does not
raise new questions
regarding safety and
efficacy. |
| Patient
Population | Individuals of all ages
and gender and shall
be assessed by the
administering dental
professional. | Individuals of all ages
and gender and shall
be assessed by the
administering dental
professional. | Individuals of all ages
and gender and shall be
assessed by the
administering dental
professional. | Not specified | Not specified | Identical |
| Descriptive
Information/
characteristic | Primary Predicate:
DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:
CleaniCal (K201799) | Secondary Predicate:
TheraCal DC (K180344) | Secondary Predicate:
Dia-Root Bio MTA
(K200174) | Differences |
| Biocompatibility
and Safety | ISO 10993 | ISO 7405:2018 | ISO 10993 | ISO 7405:2008
ISO 10993-1:2009 | ISO 7405:2018 | ISO 7405 was applied
as it is a recommended
biocompatibility
evaluation standard for
this product type. |
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VII Conclusion:
The purpose of this submission was to address the change in indications for use of the previously submitted UltraCal XS (K970114). As outlined in the comparison table above, UltraCal XS is similar to the identified predicate device with respect to its intended use, its Intended User, the Device Design, Types of Material used, Delivery System and or Deployment Method, Physical Properties and Patient Population. The subject device also successfully passed all verification and validation testing, including the biocompatibility assessment.
In summary it can be stated that the development of the subject device, UltraCal XS, is based on a well-established technology in the form of the predicate device, DiaPaste (K210333) and is chemically equivalent to the previously submitted UltraCal XS (K970114). The decision to rely on DiaPaste (K210333) as the predicate rather than the previously submitted UltraCal XS (K970114) is due to the updated indications of the subject device. In order to establish substantial equivalence, DiaPaste (K210333) was selected as the best fit predicate based off of chemistry and cleared indications for use.
Based on the completed testing and the comparisons to the predicate device, we believe that UltraCal XS is substantially equivalent to the predicate device and does not raise any different questions regarding safety and effectiveness.