(78 days)
Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures
VITRON® M is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication, repair, rebasing of complete or partial removable dentures and other removal dental appliances. VITRON® M is a pourable, cold cured denture base material
Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that the document is a 510(k) summary for a dental material (denture base material), not an AI or software-as-a-medical-device (SaMD) product. Therefore, many of the typical questions for SaMD studies (like sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
The "study" in this context is a claim of substantial equivalence to existing, legally marketed predicate devices, rather than a clinical trial demonstrating new performance metrics for a novel diagnostic device.
Here's the closest interpretation of your requests given the nature of the document:
Acceptance Criteria and Study for VITRON® M
This submission is for a denture base material, VITRON® M, and focuses on establishing substantial equivalence to existing predicate devices rather than demonstrating novel performance via a clinical study with acceptance criteria. The "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate devices) | Reported Device Performance (VITRON® M) |
|---|---|
| Intended Use: Fabrication, repair, rebasing of complete or partial removable dentures and other removable dental appliances. | Intended Use: Denture base material for completion of metal frameworks, partial and total denture rebasing, extension of partial dentures, repairs, fabrication of partial and total dentures. (Matches predicate devices like PALAPRESS® VARIO and LIQCRYLIC®). |
| Classification: Denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760). | Classification: Same as predicate devices. |
| Material Composition: Methylmethacrylate-based with barbituric acid based initiator system. | Material Composition: Consists of the "same monomers and prepolymerized oligomers" and is cured by the "same well-known barbituric acid based initiator system" as the predicate devices. (Claimed to be chemically equivalent at a high level). |
| Safety and Effectiveness: Demonstrated through long marketing history and clinical experience of predicate devices. | Safety and Effectiveness: "In our opinion biocompatibility studies are therefore not necessary to prove the safety and efficacy of VITRON® M’s formulation." "In our opinion the substantial equivalence of VITRON® M to the predicate devices... with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® M for the intended use." This assumes VITRON® M will have a comparable safety and effectiveness profile given its compositional and functional similarity to the established predicates. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a 510(k) for a dental material, not a diagnostic or AI device that would typically involve a "test set" of patient data for performance evaluation. The "test" is the comparison to predicate devices. The data provenance refers to the clinical history and market presence of the predicate devices (PALAPRESS® VARIO since 1992, LIQCRYLIC® and similar products for over 25 years in Europe/South America).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth in the traditional sense of a diagnostic agreement was established for VITRON® M in this submission. The "ground truth" for the predicate devices' safety and effectiveness is their longstanding clinical use and market history, implicitly validated by the dental community over decades.
4. Adjudication method for the test set
- Not Applicable. No "test set" or adjudication process for diagnostic performance was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI or diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the claims of safety and effectiveness for VITRON® M is derived from the long-term clinical history and established market acceptance ("outcomes data" in a very broad sense) of its predicate devices, PALAPRESS® VARIO and LIQCRYLIC®. The assumption is that because VITRON® M is chemically and functionally identical/similar to these products, it will perform similarly in clinical use.
8. The sample size for the training set
- Not Applicable. This is a physical dental material; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. (See #8)
In summary, the 510(k) for VITRON® M sought to demonstrate substantial equivalence by arguing that it shares the same intended use, fundamental technological characteristics (composition and curing mechanism), and therefore the same safety and effectiveness profile as its long-established predicate devices. The "study" supporting this is essentially a comparative analysis of the product's attributes against the known attributes and history of the predicate devices.
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K990762
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| Andreas_Petermann@ESPE.de | |
| Date: | March 3, 1999 |
Name of Device
| Proprietary Name: | VITRON® M |
|---|---|
| Classification Name: | Denture relining, repairing, or rebasing resin |
| Common Name: | Denture base material |
Predicate Devices
| PALAPRESS® VARIO by Kulzer | K 902115 |
|---|---|
| LIQCRYLIC® by Dentsply | K 972573 |
Description for the Premarket Notification
VITRON® M is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication, repair, rebasing of complete or partial removable dentures and other removal dental appliances.
VITRON® M is a pourable, cold cured denture base material and, thus similar and substantially equivalent in intended use and function to Kulzer's denture relining, repairing, or rebasing resin PALAPRESS® VARIO (K 902115) and Dentsply's LIQCRYLIC® PRO DENTAL RESIN (K 972573). Though the exact composition of PALAPRESS® VARIO and LIQCRYLIC® is not available, it is known that they consist of
Image /page/0/Picture/12 description: The image shows the text "510(k) VITRON® M ESPE". The text is arranged in three lines, with "510(k) VITRON® M" on the top line and "ESPE" on the bottom line. There is a logo to the left of the text.
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the same monomers and prepolymerized oligomers and are cured by the same well-known barbituric acid based initiator system as VITRON® M.
Kulzer's denture base material PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN are well established and determined to be safe and effective.
PALAPRESS® VARIO is marketed in the United States since 1992. Dentsply has marketed the same device as SELECTA-PLUS® and TREVAPRESS® in Europe and South America for over 25 years. The technology of methyl methacrylate based denture base materials which are cured by a barbituric acid based catalyst system is over 30 years old and has a long clinical history. In our opinion biocompatibility studies are therefore not necessary to prove the safety and efficacy of VITRON® M's formulation.
In our opinion the substantial equivalence of VITRON® M to the predicate devices PALAPRESS® VARIO and LIQCRYLIC® with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® M for the intended use.
Image /page/1/Picture/4 description: The image shows the text "510(k) VITRON M" on the top line. Below that is a logo of a tree inside of a square. To the right of the logo is the word "ESPE" in large, bold letters. The image is in black and white.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 1999
Dr. Andreas Petermann Requlatory Affairs ESPE DENTAL AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K990763 Vitron® M Trade Name: Regulatory Class: II Product Code: EBI March 3, 1999 Dated: Received: March 8, 1999
Dear Dr. Petermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Dr. Petermann
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucurullo
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Device Name:
VITRON® M
Indications for use:
Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures
Prescription use: 区
Over-the counter use □
Susan Kunz
(Division Si Division of Dental, Infection Control, and General Hospi r ´´´/k) Number
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.