(90 days)
Not Found
No
The 510(k) summary describes a dental primer, a chemical substance used for bonding. There is no mention of software, algorithms, data processing, or any other elements typically associated with AI/ML in the device description, intended use, or performance studies.
No.
The device is a primer used for bonding dental materials and repairing restorations, not for treating any disease or condition.
No
Explanation: The device, UniPrime, is described as a universal primer for bonding dental materials and for intraoral repair of fractured restorations. Its intended use focuses on adhesive and restorative procedures, not on identifying or diagnosing medical conditions.
No
The device description clearly indicates it is a "MDP containing universal primer," which is a chemical substance used for bonding dental materials. This is a physical product, 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 describes the device as a "universal primer" for bonding dental materials to various restorative surfaces (zirconia, metal/alloy, composite, ceramic) and for repairing fractured restorations. This is a dental restorative procedure, not a diagnostic test performed on samples from the human body.
- Device Description: The device description reiterates its function as a primer for bonding dental materials.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis, treatment, or prevention of disease.
- Performance Studies: The performance studies focus on adhesive strength, pH, and biocompatibility, which are relevant to the physical and biological properties of a dental material, not diagnostic accuracy.
- Predicate Device: The predicate device (Clearfil Ceramic Primer Plus) is also a dental primer, further supporting its classification as a dental restorative material rather than an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information for medical diagnosis. This device's function is entirely related to the physical bonding of dental materials within the oral cavity.
N/A
Intended Use / Indications for Use
UniPrime A is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia and metal/alloy.
UniPrime E is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia, composite and metal/alloy.
UniPrime E/C is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of ceramic, zirconia, composite and metal/alloy.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
UniPrime A is a MDP containing universal primer for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges (indications from labeling).
UniPrime E is a MDP containing universal primer for the bonding of methacrylate based. dental materials to zirconia, composite and metallalloy frameworks, crowns and bridges (indications from labeling).
UniPrime E/C is a MDP containing universal primer for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges (indications from labeling).
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)
The subject device has been evaluated for adhesive strength to indicated surfaces, pH, and biocompatiblity.
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.
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
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July 6, 2022
S&C Polymer Silicon- und Composite Spezialitäten GmbH Christian Böttcher Reg. Compliance Officer, Official Correspondent to FDA Robert-Bosch-Str. 2 Elmshorn, 25335 Germany
Re: K221033
Trade/Device Name: UniPrime A, UniPrime E, UniPrime E/C Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: March 31, 2022 Received: April 7, 2022
Dear Christian Böttcher:
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
1
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,
Srinivas Nandkumar, Ph.D. 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)
K221033
Device Name UniPrime A UniPrime E UniPrime E/C
Indications for Use (Describe)
UniPrime A
UniPrime A is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges and 2) for the intraoral restorations made of zirconia and metal/alloy.
UniPrime E
UniPrime E is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia, composite and metal/allov.
UniPrime E/C
UniPrime E/C is a MDP containing univer 1) for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral restorations made of ceramic, zirconia, composite and metal/alloy.
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 - K221033
1. Submitter
| Name of company: | S&C Polymer Silicon- und Composite Spezialitäten GmbH |
|---|---|
| Address: | Robert-Bosch-Str. 2, 25335 Elmshorn, Germany |
| Phone: | 0049 4121 483 0 |
| Fax: | 0049 4121 483 184 |
| Contact person: | Dr. Christian Böttcher |
| Date prepared: | March 31st 2022 |
2. Device name
| Trade name: | UniPrime A
UniPrime E
UniPrime E/C |
|-----------------------------|------------------------------------------|
| Common name: | Universal primer |
| Device classification name: | Agent, tooth bonding resin |
| Regulatory number: | 872.3200 |
| Product code: | KLE |
3. Device description
UniPrime A is a MDP containing universal primer for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges (indications from labeling).
UniPrime E is a MDP containing universal primer for the bonding of methacrylate based. dental materials to zirconia, composite and metallalloy frameworks, crowns and bridges (indications from labeling).
UniPrime E/C is a MDP containing universal primer for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges (indications from labeling).
4. Intended use of the devices
UniPrime A improves the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges.
UniPrime E improves the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges.
UniPrime E/C improves the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges.
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5. Indication for use of the devices
UniPrime A is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia and metal/alloy.
UniPrime E is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia, composite and metal/alloy.
UniPrime E/C is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of ceramic, zirconia, composite and metal/alloy.
6. Device for which substantial equivalence is claimed
| Subject device: | UniPrime A |
|---|---|
| UniPrime E | |
| UniPrime E/C | |
| Predicate device: | Clearfil Ceramic Primer Plus (Kuraray) |
| 510(k) Number: | K150703 (introduced into the US-Market 2015) |
6.1. Device comparison with the predicate device
The predicate device has been found to be substantially equivalent under the 510(k) premarket notification as class II dental device under CFR 872.3200 product code KLE.
| | Subject devices
UniPrime A
UniPrime E
UniPrime E/C | Predicate device
Clearfil Ceramic Primer
Plus (Kuraray) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | MDP containing universal
primer for the bonding of
methacrylate based dental
materials to ceramic,
zirconia, composite and
metal/alloy frameworks,
crowns and bridges.* | Clearfil Ceramic Primer Plus |
| Intended use | UniPrime improves the
bonding of methacrylate
based dental materials
to ceramic, zirconia,
composite and metal/alloy
frameworks, crowns and
bridges.* | Clearfil Ceramic Primer Plus is
a dental universal prosthetic
primer that provides an
enhanced adhesive surface to
ceramic, hybrid ceramics,
composite resin and metal. |
| Prescription use | yes | yes |
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| Mechanism of action | equal | equal |
|---|---|---|
| Form of delivery | bottle | bottle |
| Indications for use | UniPrime II improves the | |
| bonding of methacrylate | ||
| based dental materials | ||
| to ceramic, zirconia and | ||
| metal/alloy frameworks, | ||
| crowns and bridges.* | Clearfil Ceramic Primer Plus | |
| is indicated for the following | ||
| uses: | ||
| -Surface treatment of | ||
| prosthetic restorations made of | ||
| ceramic, hybrid ceramics, | ||
| composite resin or metal | ||
| Intraoral repairs of fractured | ||
| Restorations made of ceramic | ||
| hybrid ceramics, composite | ||
| resin or metal | ||
| Ingredients | Solvent | |
| MDP | ||
| Silane * | Solvent | |
| MDP | ||
| Silane* |
- product specific information
7. 1 Conclusion
The comparison worked out above and the further elaboration of information within this 510(k) submission demonstrate that the subject devices UniPrime A, UniPrime E and UniPrime E/C are substantially equivalent to the predicate device Clearfil Ceramic Primer Plus (Kuraray) in terms of description, intended use, indications for use, chemical composition and physical properties. The subject device has been evaluated for adhesive strength to indicated surfaces, pH, and biocompatiblity. The information given above do not raise different questions of safety and effectiveness. The devices are as safe and effective as the predicate device.