(1 days)
No
The description focuses on the chemical and physical properties of a dental cement and does not mention any computational or analytical functions that would typically involve AI/ML.
No
The device is a resin cement used for assembling prosthetic components, not a device that directly treats a disease or condition.
No
The device is a resin cement used for bonding prosthetic components, not for diagnosing medical conditions.
No
The device description clearly states it is a "two-component, self-cure, high strength self-adhesive cement," 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 clearly states the device is for the "cementation of: Extraoral assembly of prosthetic components". This describes a process performed outside the body to assemble dental prosthetics.
- Device Description: The description details a "two-component, self-cure, high strength self-adhesive cement" used for bonding materials like titanium and ceramic. This is consistent with a dental cement used for prosthetic assembly.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device's function is purely mechanical/adhesive for assembling dental components.
Therefore, Calibra Abutment Resin Cement is a dental cement used for extraoral assembly of prosthetic components, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement. Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired. Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.
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
Not Found
Intended User / Care Setting
Not Found
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)
Test data to verify the performance of the proposed Calibra Abutment Resin Cement has been provided including work time, set time, film thickness, consistency, flexural strength and bond strength to multiple prosthetic components. The results show that the proposed device meets the requirements of the non-clinical bench testing conducted to support substantial equivalence. A biological risk assessment was conducted on the proposed device, Calibra Abutment Resin Cement, upon the review of available information on raw materials, manufacturing processes, chemical characterization tests and existing preclinical biological testing data. Overall, when considering the full complement of results available, this risk assessment indicates that the likelihood of a toxic effect from the proposed device, Calibra Abutment Resin Cement, is low.
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.
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.
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 2, 2024
Dentsply Sirona % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K240888
Trade/Device Name: Calibra Abutment Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA Dated: March 30, 2024 Received: April 1, 2024
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.
1
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 -S
Michael E. Adjodha, MChE, RAC, CQIA 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
2
Indications for Use
510(k) Number (if known)
Device Name Calibra Abutment Resin Cement
Indications for Use (Describe) Calibra Abutment Resin Cement is indicated for the cementation of:
Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.
| 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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3
K240888
510(k) SUMMARY for
Calibra Abutment Resin Cement
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Rebecca Sporer |
|---|---|
| Telephone Number: | 717-849-4793 |
| Email: | Corporate-RA@dentsplysirona.com |
Date Prepared:
20 March 2024
2. Device Name:
- . Proprietary Name: Calibra Abutment Resin Cement
- . Classification Name: Dental Cement
- CFR Number: 872.3275 ●
- Device Class: Class II ●
- EMA Product Code: .
-
- Predicate/Reference Devices:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Multilink Hybrid Abutment Cement | K130436 | Ivoclar Vivadent |
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| Self-Adhesive Resin Cement | K073173 | Dentsply Sirona |
4
4. Description of Device:
Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement.
Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired.
Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.
5. Indications for Use:
Calibra Abutment Resin Cement is indicated for the cementation of:
Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.
6. Technological Comparison:
Calibra Abutment Resin Cement incorporates similar fundamental technology (principle of operation, material form, mixing ratio, polymerization method, and delivery system) as the predicate device, Multilink Hybrid Abutment cement (K130436). Calibra Abutment Resin Cement incorporates similar fundamental technology (differ in polymerization method) and is similar in formulation to the reference device Self-Adhesive Resin Cement (K073173). The reference device Self-Adhesive Resin Cement (K073173) is being incorporated for comparison to shelf-life and biocompatibility. The proposed Calibra Abutment Resin Cement is available in one shade, opaque, when compared to the predicate and reference devices which are available in more than one shade.
7. Non-Clinical Tests Summary and Conclusion:
Test data to verify the performance of the proposed Calibra Abutment Resin Cement has been provided including work time, set time, film thickness, consistency, flexural strength and bond strength to multiple prosthetic components. The results show that the proposed device meets the requirements of the non-clinical bench testing conducted to support substantial equivalence.
A biological risk assessment was conducted on the proposed device, Calibra Abutment Resin Cement, upon the review of available information on raw materials, manufacturing processes, chemical characterization tests and existing preclinical biological testing data. Overall, when considering the full complement of results available, this risk assessment indicates that the likelihood of a toxic effect from the proposed device, Calibra Abutment Resin Cement, is low.
5
-
- Clinical Tests Summary and Conclusion: Not applicable.
-
- Substantial Equivalence:
Table 9.1 compares the indications for use of the proposed device, Calibra Abutment Resin Cement, to the predicate device, Multilink Hybrid Abutment Cement (K130436).
| Table 9.1-Comparison of Indications For Use between the proposed and the predicate devices | ||
|---|---|---|
| Proposed Device | Predicate Device | Comparison Discussion |
| Calibra Abutment Resin Cement | Multilink Hybrid Abutment | |
| Cement (K130436) | ||
| Calibra Abutment Resin Cement is indicated for the cementation of: |
Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases | Multilink Hybrid Abutment Cement is indicated for extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic | The proposed Calibra Abutment Resin Cement and the predicate device, Multilink Hybrid Abutment Cement (K130436) are both indicated for the extraoral assembly of appliances. |
10. Conclusion Regarding Substantial Equivalence:
Calibra Abutment Resin Cement is a dental cement which is intended for the extraoral cementation assembly of prosthetic components. Calibra Abutment Resin Cement has the same intended use, incorporates the same fundamental technology and has similar indications for use as the predicate Multilink Hybrid Abutment cement (K130436). Calibra Abutment Resin Cement incorporates similar fundamental technology and is similar in formulation to the reference device Self-Adhesive Resin Cement (K073173). Test data to verify the performance of the proposed Calibra Abutment Resin Cement has been provided including work time, set time, film thickness, consistency, flexural strength and bond strength to multiple prosthetic components. The results of this testing, combined with the design comparison with the predicate device Multilink Hybrid Abutment Cement (K130436) and the reference device Self-Adhesive Resin Cement (K073173), support substantial equivalence.