(1 days)
No
The summary describes a flowable resin material and its intended uses, with no mention of AI or ML technology.
No
The device is described as a material for temporary dental restorations and other dental procedures, such as splinting and bite ramps. It does not appear to treat or cure any medical condition or disease, which is typically the purpose of a therapeutic device.
No
The intended uses listed (temporary restorations, splinting, isolation, bite ramps, temporary occlusal buildups) are all related to treatment or support during dental procedures, not to diagnosing a condition.
No
The device description clearly states it is a "flowable resin material" delivered via syringe and light cured, indicating it is a physical material, 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 are all related to direct dental procedures performed on a patient's teeth and mouth (temporary restorations, splinting, isolation, bite ramps). These are not tests performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The device is a flowable resin material applied directly to the teeth and light-cured. This is a material used for treatment and restoration, not for diagnostic testing.
- Lack of Diagnostic Purpose: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Temporary restorations
- Splinting between implant copings for impressions to resist impression material distortion
- To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
- Bite ramps and temporary occlusal buildups during orthodontics
Product codes
EBF
Device Description
J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The subject device successfully passed all verification and validation testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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July 1, 2022
Ultradent Products, Inc. % Dave Yungvirt Most Responsible Person Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K221909
Trade/Device Name: J-Temp Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: June 27, 2022 Received: June 30, 2022
Dear Dave Yungvirt:
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.
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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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
J-Temp
Indications for Use (Describe)
·Temporary restorations
·Splinting between implant copings for impressions to resist impression material distortion
·To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
· Bite ramps and temporary occlusal buildups during orthodontics
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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K221909
510(k) Summary
This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 J-Temp.
l. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Mr. Matthew Buck |
|---|---|
| Title: | Regulatory Affairs Specialist III |
| Telephone: | 801-553-4339 |
| Cell Phone: | 801-201-2371 |
| Fax: | 801-553-4609 |
Date Summary Prepared: 20 May 2022
II. Name of the Device
| Device: | Material, Tooth Shade, Resin |
|---|---|
| Trade/Device Name: | J-Temp |
| Common Name: | Material, Tooth Shade, Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3690 |
| Device Class: | Class II |
| Classification Product Code: | EBF |
III. Device Description
J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.
IV. Statement of Intended Use
J-Temp is indicated for
- Temporary restorations ●
- . Splinting between implant copings for impressions to resist impression material distortion.
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- . To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
- . Bite ramps and temporary occlusal buildups during orthodontics
V. Predicate Device
J-Temp identified primary predicate: Clip Flow by Voco (K153493)
VII. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of J-Temp are substantially equivalent to the identified predicate as outlined in Table 5-1:
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Table 5-1: UltraTemp REZ II substantial equivalence comparison
| Descriptive
Information/
characteristic | Predicate: Clip Flow
(K153493) | Device: J-Temp | Reference: Venus Flow
(K033665) | Reference: TKO
Composite Bite
Turbo Gel
(K210349) | Identified Characteristic
Differences and Rationale for
Differences |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EBF | EBF | EBF | EBF | Same |
| Intended Use | [A] Temporary inlay
and onlay treatments
of the cavity
[B] Sealing of openings
for implant screws
[C] Relining material
for temporary crowns
and bridges
[D] Block-out material
for retentive areas in
the dental arch, e.g.
before taking
impressions
[E] Covering of the
gingival margin
[F] Fixing of resin
matrix during filling
placement
[G] Temporary filling
of cavities | •Temporary
restorations
•Splinting between
implant copings for
impressions to resist
impression material
distortion
•To provide structure
for isolation clamping
and to act as a barrier
for endodontic
irrigants
•Bite ramps and
temporary occlusal
buildups during
orthodontics | Venus flow is a flowable,
light curing, radiopaque
hyrbrid composite used for
adhesive, tooth-colored
anterior and posterior
restorations. Due to its low
viscosity Venus Flow
provides excellent coverage
tooth structure.
Applicable applications
includes:
Baseliner in Class I & II
cavities; Fissure sealing;
Enlarged fissure sealing;
Class V fillings; Minimally
invasive Class I and II fillings
in areas not subjected to
masticatory forces;
Minimally invasive Class III
fillings; Smaller contour and
shade adjustment on the
enamel and dentine; Small
surface repairs to direct and
indirect restorative in | TKO is a pink,
flowable light
cure composite
gel for the
creation of
occlusal buildups
(bite turbos) and
as a retainer
repair
composite. | Both Clip Flow and J-Temp have the
same intended use with minor
differences in their Indications for
use. Clip Flow is indicated for
temporary inlay and onlay
treatments of the cavity, temporary
filling of cavities. J-Temp is
indicated for temporary
restorations. J-Temp is indicated for
providing structure for isolation
clamping acting as a barrier for
endodontic irrigants, because when
cured it is harder than Clip Flow it
can be used in this specific
procedure as part of a temporary
filling. Because J-Temp is harder
when cured it can be indicated for
splinting between implant copings
for impressions to resist impression
material distortion, like the
reference device Venus Flow which
has an indication to splint teeth. J-
Temp can also be indicated for Bite
ramps and temporary occlusal
buildups during orthodontics like |
| | | | combination with a suitable
bonding agent; Splinting
teeth ; Cavity lining;
Bracket retention; Sealing
endodontically treated
teeth; Luting porcelain or
composite veneers; Filling
in voids in temporary crown
and bridges materials | | the reference device TKO
Composite Bite Turbo Gel. |
| Intended User | Licensed Dentist or
Dental Professional | Licensed Dentist or
Dental Professional | Licensed Dentist or Dental
Professional | Dental
Professional | Same intended user. No identified
differences. |
| Characteristics | • Flowable, light-
cured temporary
restorative
material.
• Elastic consistency
and removable with
probe. | • Flowable, light-
cured temporary
restorative
material.
• Cured resin
removable with
dental bur. | • Flowable, light-cured
restorative material. | • Flowable,
light-cured
composite Gel | Clip Flow and J-Temp are flowable
light-cured temporary restorative
materials. They are both intended
to be easily removed as temporary
materials unlike the reference
devices. |
| Composition | • Methacrylates
• Light cure initiators
BHT | • Methacrylates
• Light cure initiators
• Glass ionomer fillers
Pigments | • Methacrylates
• Light cure initiators
• Barium Aluminum Boro
Fluor Silicate fillers
• Pigments
• BHT | • Methacrylates
• Light cure
initiators
Pigments | Clip Flow and TKO Composite Bite
Turbo Gel don't have fillers.
Rationale for differences: J-Temp
and Venus Flow have indications for
use that require a harder material.
J-Temp doesn't need BHT which is
free radical inhibitor. |
| Delivery System
or Deployment
Methods | Product is provided in
a 1.8g syringe with
disposable delivery
tips | Product is provided in
a 1.2mL syringe with
disposable delivery
tips | Product is provided in a
1.8g syringe | Product is
provided in a
precision 3.5 gm
LuerLoc syringe
with tips | Clip Flow and the J-Temp are
provided in similar delivery syringes
along with the reference devices. |
| Physical
Properties | Flowable Used with tips. Light cured ≤ 5 % shrinkage ≥ 10 HK Hardness ≥ 1 mm depth of cure | Flowable Used with tips. Light cured ≤ 5 % shrinkage ≥ 10 HK Hardness ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur Radio-opaque | Flowable Used with tips. Light cured ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur Radio-opaque | Flowable Used with tips. Light cured. ≥ 10 HK Hardness ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur | J-Temp is harder when cured than
Clip Flow. J-Temp has a hardness
value comparable to TKO
Composite Bite Turbo Gel. J-Temp's
flexural strength is less than Venus
Flow and to TKO Composite Bite
Turbo Gel. J-Temp is radio-opaque,
and Clip Flow is not radio-opaque. |
| Patient
Population | is suitable for use in all
patients without any
age or gender
restrictions | Individuals of all ages
and gender and shall
be assessed by the
administering dental
professional. | The dental material is
suitable for patients
requiring dental treatment
for the indications | Individuals
receiving
orthodontic
treatment. | N/A |
| | | | with consideration of the
contraindications. | | |
| Biocompatibility
and Safety | Biocompatible | Tested per ISO 7405,
ISO 10993-1
•Physical/Chemical
Information
•Systemic Toxicity
•Genotoxicity
•Cytotoxicity
•Sensitization
•Irritation
•Implantation Effects | Biocompatible | ISO 10993-5
ISO 7405:2018 | The Clip Flow and J-Temp are
shown to be biocompatible as well
as the reference devices. |
| | | | | | |
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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
8
Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
9
VII Conclusion:
As outlined in the comparison table above, J-Temp 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. Also, J-Temp does not introduce any new safety or efficacy issues, questions or concerns per Biocompatibility and Safety testing that has been completed. The subject device also successfully passed all verification and validation testing.
In summary it can be stated that the development of the subject J-Temp product is based on a well-established technology in the form of the predicate Clip Flow product. Based on these comparisons to the predicate device, we believe that J-Temp is substantially equivalent to the predicate device and do not raise new concerns of safety or efficacy.