(199 days)
Not Found
No
The description focuses on the material composition and compatibility with existing CAD/CAM milling systems, with no mention of AI or ML in the device's function or fabrication process.
No
This device is a composite block used to fabricate dental restorations, which are considered prosthetics rather than therapeutic devices that treat a disease or condition.
No
Tetric® CAD is a composite block used for fabricating dental restorations like veneers and crowns, not for diagnosing medical conditions.
No
The device description clearly states it is a "composite block" and describes its physical composition and use in a milling machine, indicating it is a physical material, not software.
Based on the provided information, Tetric® CAD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Tetric® CAD's Function: Tetric® CAD is a composite block used to fabricate dental restorations (veneers, inlays, onlays, crowns). It is a material that is milled and then placed in the patient's mouth. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for fabricating dental restorations, not for diagnostic purposes.
- Device Description: The description focuses on the material composition and how it's used in a milling machine to create a physical restoration.
- Performance Studies: The performance studies mentioned are related to the physical properties and biocompatibility of the material, not diagnostic accuracy or performance on biological samples.
Therefore, Tetric® CAD falls under the category of a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
Tetric® CAD is intended for:
- Veneers
- Inalys
- Onlays (e.g. occlusal veneers, partial crowns)
- Crowns in the anterior and posterior region
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).
Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior region (referring to teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist's office
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)
Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: water solubility according to ISO 10477:2004 and flexural strength according to ISO 6872:2015. 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 testing was conducted according to ISO 10993-1:2009 +AC:2010. Specific tests conducted were Cytotoxicity according to EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009 and Genotoxicity according to 10993-3:2014. The device was found to be non-cytotoxic and non-genotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: Typical mean value (IFU): 272 MPa
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.
Cerasmart (K133824) by GC America, Inc.
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.
Not Found
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
§ 872.3690 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 shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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 square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ivoclar Vivadent AG % Donna Hartnett Director QA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K173573
Trade/Device Name: Tetric® CAD Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 3, 2018 Received: May 8, 2018
Dear Donna Hartnett:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
June7, 2018
1
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 medical devices and radiation-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.
Mary S. Runner -S
forTina 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
2
Indications for Use
510(k) Number (if known) K173573
Device Name Tetric® CAD
Indications for Use (Describe)
Tetric® CAD is intended for:
-
Veneers
-
Inalys
-
Onlays (e.g. occlusal veneers, partial crowns)
-
Crowns in the anterior and posterior region
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
Image /page/3/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in green and "Vivadent" in blue. The tagline "passion vision innovation" is written in a smaller font below the company name. The logo also includes a series of green and blue dots and squares arranged in an arc above and to the right of the company name.
| Contact: | Donna Hartnett, Director QA/Regulatory
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-691-2260
Donna.hartnett@ivoclarvivadent.com |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 2, Schaan, FL-9494, Liechtenstein
+423-235-3535 |
| Date Prepared: | June 5, 2018 |
| Proprietary Name: | Tetric® CAD |
| Classification Name: | Material, Tooth Shade, Resin (872.3690)
(Product Code: EBF) |
| Predicate Device: | Cerasmart (K133824) by GC America, Inc. |
Tetric® CAD is a composite block for the fabrication of esthetic Device Description: permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).
Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.
Indications for Use:
Tetric® CAD is intended for:
- Veneers "
- -Inalys
- -Onlays (e.g. occlusal veneers, partial crowns)
- Crowns in the anterior and posterior region -
4
Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar" and "Vivadent" stacked on top of each other. Above the words are a series of green dots and squares. The logo is simple and modern, and it is likely used to represent the company's brand.
510(K) SUMMARY
Comparison to Predicate: The primary predicate devices to which Tetric® CAD has been compared is GC Americ a's Cerasmart (K133824).
| Device | GC America: Cerasmart (K133824) | Ivoclar Vivadent: Tetric® CAD (K173573) |
|---|---|---|
| Indications for Use | The product is indicated for inlays, onlays, | |
| veneers and full crown restorations, | ||
| including crowns on implants. | Tetric® CAD is intended for: |
- Veneers
- Inlays
- Onlays (e.g. occlusal
veneers, partial crowns) - Crowns in the anterior and
posterior region |
| Precaution Measures/
Contraindications/
Processing restrictions/
Side effects | In rare cases this product may cause
sensitivity in
some people. If such reactions are
experienced, discontinue
the use of product and consult a physician.
Personal protective equipment such as
gloves, face
masks and safety eyewear should always be
worn. | Contraindications: - Bridge constructions
- Conventional and self-adhesive
cementation - Temporary cementation
- Patients with severely reduced residual
dentition - Any other use not listed in the indications
Failure to observe the following restrictions
may compromise
the results achieved with Tetric® CAD: - Falling short of the required minimum
layer
thicknesses - Milling the blocks in a non-compatible
CAD/CAM system - Deviations from the recommended luting
protocol
If a patient is known to be allergic to any of
the ingredients of Tetric® CAD, the material
should not be used.
Do not inhale the composite resin dust
during finishing.
Use suction equipment and wear a dust
mask |
| Summary of
Indications, Precaution
Measures/
Contraindications/
Processing restrictions/
Side effects | The precautions, processing restrictions and contraindications are described in more detail
for Tetric® CAD, but in total the indications and contraindications are substantially
equivalent. | |
| Technology | Cerasmart is a pre-cured composite block
for milling CAD/CAM indirect restorations.
The milled device is used for the
restorations of both anterior and posterior
teeth. | Tetric® CAD is a composite block for the
fabrication of permanent inlays, onlays,
veneers and crowns in the anterior and
posterior region.
In this processing technique, the
restoration is polished and incorporated
immediately after milling in the CAD/CAM
system. |
| Summary of Technology
Delivery forms/dosage | The devices are similar, there is a minor difference in the wording.
The blocks are available in 3 sizes (12, 14,
14L) in 33 shades (Translucency HT, LT and
one Bleach shade). | The blocks are available in the
translucency levels MT and HT, in 5 and 4
shades respectively, and in the sizes I12
and C14. |
| Summary of Delivery
forms/dosage | The predicate device is available in 3 sizes, one more than Tetric® CAD (14L is not
available for Tetric® CAD). Additionally the predicate device offers 33 shades
(Translucency HT, LT and a Bleach shade), Tetric® CAD offers 5 shades for MT and 4
shades for HT. Even though less shades are available the dentist can still meet the
aesthetic demands of the patient. | |
| Storage Conditions | Storage at room temperature (4 - 25 $^{\circ}$ C/39.2 -
77.0 $^{\circ}$ F), away from direct sunlight and
high humidity;
Shelf life: 5 years from date of manufacture | Storage conditions: 2 - 28 $^{\circ}$ C/36 - 82 $^{\circ}$ F,
avoid sunlight
Shelf life: 36 months |
| Summary of Storage
Conditions | The recommended shelf life is shorter for the new product, as less data is currently
available. | |
| Principles of Operation | Step by Step:
-Preparation Design, shade selection
-Scanning and Milling
-Finishing and polishing
-Characterization
-Pre-Treatment
-Cementation
-Maintenance and repair | Step by Step: - Preparation, shade determination
- Intraoral imaging, CAD/CAM process
- Polishing
- Characterization
- Preparing for cementation
- Cementation
- Checking the articulation/occlusion,
polishing - Aftercare |
| Summary Principles of
operation | There are minor differences in the wording between the predicate and the new product
Tetric® CAD, but these are not significant and the principle of the operation is substantially
equivalent. | |
| Summary Chemical
Composition | Both products are pre-cured composite blocks with differences in composition. Tetric® CAD
has evaluated biocompatibility according to ISO 10993- 1:2009. | |
| Finished Device
Specification | Applicable standard: No information
Applicable FDA Guidance: No information | EN 1641:2009 – Dentistry - Medical
devices for dentistry -
Materials
Dental Composite Resin Devices –
Premarket Notification
[510(k)] Submission |
| Sensitivity to light | Not relevant - industrially cured | Not relevant - industrially cured |
| Color stability | Not relevant - industrially cured | Not relevant - industrially cured |
| Flexural
Strength | Brochure: 238 MPa | Typical mean value (IFU): 272 MPa |
| Sterilization | Not applicable. No sterilization
recommendation. | Not applicable. No sterilization
recommendation. |
| Single use | Consumable material | Consumable material |
| Summary of Finished
Device Specification | Tetric® CAD fulfils the relevant standard and follows the relevant Guidance. | |
| Summary of
Performance
Specification | The value for flexural strength of Cerasmart (GC`s brochure) correlates with Ivoclar
Vivadent's Tetric® CAD. | |
5
510(K) SUMMARY
Image /page/5/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is in two lines, with "ivoclar" on the first line and "vivadent" on the second line. The word "ivoclar" is in green, and the word "vivadent" is in blue. There is a series of green and blue dots above the word "ivoclar".
3
Substantial equivalence to the predicate:
The subject and the predicate device are pre-cured composite blocks for milling CAD/CAM restorations. Thus, the devices have the same function, have similar principles of operation and a similar chemical composition. The forgoing comparison supports that the subject device is substantially equivalent to the predicate device.
Differences :
The recommended storage temperature is marginally different (2-28 °C) compared to 4-25 °C for the predicate device. This is not substantial and is due to company policy. The shelf life is shorter (36 months) compared to 5 years for the predicate device. This is not substantial and is due to ongoing real-time testing.
6
510(K) SUMMARY
Image /page/6/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in a darker blue and "Vivadent" in a lighter blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the slogan "passion vision innovation" in a smaller font.
The chemical composition is not fully published for the predicate device and therefore it is assumed there is some difference in ingredients, although the published data shows both products to be 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: water solubility according to ISO 10477:2004 and flexural strength according to ISO 6872:2015. 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 +AC:2010. 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 10993-3:2014 and the device was found to be non-cytotoxic and non-genotoxic.
Conclusion: The data show that Tetric® CAD is substantially equivalent to the predicate device.