(98 days)
Not Found
No
The summary describes a light-curing resin-based composite material and its physical properties, with no mention of AI or ML technology.
No
The device is a dental restorative material (resin-based composite) used for filling cavities and restoring teeth, not for treating diseases or conditions.
No
The device description clearly states "Tetric® PowerFill is a light-curing radiopaque resin-based composite for the direct restorative treatment in posterior teeth." This indicates its use for treatment, not diagnosis. The "Intended Use / Indications for Use" section also lists various types of restorations, further confirming its therapeutic purpose.
No
The device description clearly states it is a "light-curing radiopaque resin-based composite," which 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 use describes the device as a material for direct restorative treatment in posterior teeth. This involves physically filling and restoring damaged tooth structure within the patient's body.
- Device Description: The description details the composition of a light-curing resin-based composite material used for dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. This device is a restorative material applied directly to the tooth.
N/A
Intended Use / Indications for Use
- Conventional application (Light intensity
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K183380
Trade/Device Name: Tetric® PowerFill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 21, 2018 Received: December 26, 2018
Dear Lori Aleshin:
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
March 14, 2019
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Mary Mary S. = Mary 3. S. Runner -S3
Date: 2019.03.14 09:38:49
-04'00' - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183380
Device Name Tetric® PowerFill
Indications for Use (Describe)
-
Conventional application (Light intensity ≤2,000 mW/cm2):
-
Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
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Class V restorations (cervical caries, root erosion, wedge-shaped defects)
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Reconstructive build-ups
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Restoration of deciduous teeth
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Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2):
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Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect
| 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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Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in a bold, sans-serif font, with the words "passion vision innovation" written in a smaller font below. Above the company name is an arc of green and blue dots and squares. The green dots are on the left side of the arc, and the blue squares are on the right side of the arc.
| Contact: | Lori Aleshin, Director of Quality and Regulatory Affairs
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-691-2045
lori.aleshin@ivoclarvivadent.com |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 2, Schaan, FL-9494, Liechtenstein
+423-235-3535 |
| Date Prepared: | December 4, 2018 |
| Proprietary Name: | Tetric® PowerFill |
| Classification Name: | Material, Tooth Shade, Resin (872.3690)
(Classification Code EBF) |
| Predicate Device: | Tetric EvoCeram Bulk Fill (K111958) by Ivoclar Vivadent |
Tetric® PowerFill is a light-curing radiopaque resin-based Device Description: composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (Safety notes
- Do not place light in direct contact
with unprotected gingiva, mucous
membrane or skin. - The 3sCure curing mode must not be
used in case of caries profunda and
very deep cavities. |
| Summary of
Indications, Precaution
Measures/
Contraindications/
Processing restrictions/
Side effects | The new device Tetric PowerFill lacks the indication "Extended fissure sealing in
molars and premolars" in contrast to the predicate device and includes the
indication "reconstructive build-ups". Extended fissure sealing is a feature that
has established itself for flowable composites and is therefore not intended for
Tetric PowerFill. All composites that can be used for direct occlusion fillings can
also be uses as reconstructive buildup materials as they have the physical
characteristics therefore.
According to this the indication has been added to the new device Tetric
PowerFill.
The contraindications are the same for both devices.
Side effects and warnings are the same. The safety notes are an addition for the
new device because of the curing time of 3 seconds with a polymerization light
with a light intensity of 3,050 mW/cm2. | |
| Technology | Tetric EvoCeram Bulk Fill is a light-
curing, radiopaque nano-hybrid
composite for direct restorations in
posterior teeth. Tetric EvoCeram Bulk
Fill cures with light in the wavelength
range of 400-500 nm and can be
applied in layers of up to 4 mm. | Tetric PowerFill is a light-curing
radiopaque composite for the direct
restorative treatment in posterior teeth.
Tetric PowerFill cures with light in the
wavelength range of 400-500 nm and
can be applied in layers of up to 4mm.
While using the 3sCure mode of
Bluephase Power- Cure
(3,050mW/cm2), the material can be
cured within 3 seconds. |
| Summary of Technology | The working principle for both devices is substantially equivalent: both products
are light-curing resin-based dental restorative materials. Tetric PowerFill can be
cured with a dental curing light with a light intensity ≤ 2,000 mW/cm2 like its
predicate.
The innovation of the new device Tetric PowerFill is that the device can be cured
within 3 seconds using a curing light with a light intensity of 3,050 mW/cm2 for
class I and II restorations in the posterior region. | |
| Delivery forms/dosage | Syringes and cavifils | Syringes and cavifils |
| Summary of Delivery
forms/dosage | No difference. | |
| | | passion vision innovation |
| Storage Conditions | 48 months at 2-28 °C / 36-82 °F | 48 months at 2-28 °C / 36-82 °F |
| Summary of Storage Conditions | No difference. | |
| Principles of Operation | Step-by-step: | Step-by-step: |
| | - Shade determination - Isolation - Cavity preparation - Pulp protection /Base - Apply matrix /interdental wedge - Conditioning / Application of the bonding agent - Application of Tetric Evoceram Bulk Fill - Finishing / Checking the occlusion / Polishing | - Shade determination - Isolation - Cavity preparation - Pulp protection/Base (3sCure mode is mentioned) - Apply matrix / interdental wedge - Conditioning/Application of the bonding agent - Application of Tetric PowerFill - Finishing /Checking the occlusion / Polishing |
| Summary Principles of operation | The slight differences in the application are explained by the 3sCure mode of a curing light with a light Intensity of 3,050 mW/cm2.
The principles of operation for the predicate and the new device are substantially equivalent. | |
| Finished Device Specification | Applicable standard: ISO 4049:2009- Dentistry - Polymer-based restorative materials
Applicable FDA Guidance: No information | Applicable standard: ISO 4049:2009- Dentistry- Polymer-based restorative materials
Dental Composite Resin Devices – Premarket Notification [510(k)] Submission |
| Sterilization | Not applicable. No sterilization recommendation. | Not applicable. No sterilization recommendation. |
| Single use | Consumable material | Consumable material |
| Summary of Finished Device Specification | Tetric® PowerFill fulfils the relevant standard and follows the relevant Guidance. | |
| Summary of Performance Specification | The performance of the new device Tetric PowerFill is substantially equivalent to the predicate device. | |
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Image /page/5/Picture/1 description: The image shows the Ivoclar Vivadent logo, which features the company name in blue with the tagline "passion vision innovation" underneath. Above the company name, there is a curved line of colored dots in green and blue. To the right of the logo, there is a number 3.
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Image /page/6/Picture/1 description: The image shows the Ivoclar Vivadent logo. The logo is blue and green, and it says "Ivoclar Vivadent" in a stylized font. Below the name is the text "passion vision innovation". To the right of the logo is the number 4.
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Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" underneath. Above the company name is an arc of green and blue squares. To the right of the logo is the number 5.
Substantial equivalence to the predicate:
Both devices, the predicate Tetric EvoCeram Bulk Fill and the new device Tetric PowerFill are light-curing resin-based dental restorative composite devices. The physical properties are the same for both devices, the composition has been slightly changed for the new device.
Differences:
The slight differences in the application are explained by the 3sCure mode of a curing light with a light Intensity of 3,050 mW/cm2.
The principles of operation for the predicate and the new device are substantially equivalent.
Non-clinical performance testing:
Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, curing depth, sensitivity to light, wavelength for curing, water sorption and water solubility and radiopacity according to ISO 4049:2009. The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent.
Biocompatibility:
The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2008 and ISO 14971:2012. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009 and Genotoxicity according to EN ISO10993-3:2014 and the device was found to be non-cytotoxic and nongenotoxic. In addition to testing, additional criteria for biocompatibility including irritation, delayedtype hypersensitivity/Sensitization, systemic toxicity, implantation, and pulp and dentine usage were also evaluated based on a review of the literature and the evaluation concluded the benefits provided by the subject device will exceed any potential biocompatibility risks. This supports a finding of substantial equivalence due to the biocompatibility of the predicate device.
The Subject device was not tested or evaluated for pulp capping, endodontic usage, biodegradation, EMC, Software, animal and sterility validation as they are not applicable.
The results of the Biocompatibility Assessment for Tetric PowerFill is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Tetric EvoCeram Bulk Fill.
Conclusion:
The new device Tetric PowerFill is substantially equivalent to the predicate device Tetric EvoCeram Bulk Fill.